Category: Uncategorized

In the world of medical device testing, manufacturers should seek to identify key characteristics that set a high-quality laboratory aside from the rest. A successful medical device testing relationship should be built on trust, quality, and integrity. Some potential consequences for choosing an incapable third-party testing partner include inaccurate results, legal liability, regulatory compliance issues, wasted resources, and more. Most importantly, failure to achieve FDA approval or regulatory approval can lead to timely delays, wasted products, and the loss of business opportunities. 

 

How to identify a medical device testing partner

 

While the cost of medical device testing is often a determining factor, it’s essential to consider the cost of quality when selecting a testing partner. Additionally, assessing the laboratory’s ability to deliver testing results within required timelines without compromising quality is an advantage. It is critical not to be misled into unrealistic turnaround times or lower costs that could lead to re-testing and/or delays due to unreliable data driven by a lack of competence in testing. High-quality reliable data you can trust comes with appropriate timelines required to support critical sample preparation, strict quality control measures, and complex analysis.

 

In addition to cost and turnaround time, be sure to look for the following criteria when choosing a medical device testing laboratory to support your products:

 

A strong quality system

 

Quality management systems (QMS) are essential to ensure the reliability of all aspects of testing. From safeguarding the accuracy and confidence of results to the implementation of quality control measures, a strong QMS contributes to greater trust in 3rd party testing. One that has been regularly audited by the FDA is favorable.

 

Actively participates in standard development

 

Continued involvement at industry meetings including standard development keeps testing laboratories at the forefront of regulatory science and enables them to help you make the right testing decisions that are compliant and widely accepted. Technical expertise and experience go a long way in the proper support and understanding of the ever-evolving world of standards.

 

Upholds proper accreditation (ISO 17025)

 

The first sign of technical competence is accreditation to ISO 17025 which specifies the general requirements to carry out tests and/or calibrations, including sampling. Compliance with the FDA’s ASCA program is also desirable in addition to other industry-specific organizations. Accreditation demonstrates 3rd party testing compliance with international standards and ensures the credibility of lab testing services.

 

Robust regulatory resources

 

Internal subject matter experts who understand the complexities of globally regulated manufacturers will lead to more successful testing outcomes. Selecting a third-party laboratory that offers in-house expertise in this area can help reduce the regulatory feedback burden.

 

Customer-driven

 

Reliable and accurate medical device testing results are essential for maintaining customer satisfaction. Since a test report is often the final product provided by a testing laboratory, the overall customer success should be highlighted as critical to the overall success of the laboratory.

 

By specifically evaluating these factors, you can identify a strong third party testing partner that meets your specific testing needs and standards of quality, reliability, and competence.

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. Our regulatory compliance solutions for law firms include remediation services for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Medical Device Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of medical device cybersecurity services to ensure your product is protected from cyberattacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consulting Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle. The RCA medical device consultant team understands protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone. We handle more regulatory consulting submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and/or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights that increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and regulatory consulting team represents Regulatory Compliance Associates® as one of the top medical device consulting firms. We’ll help you navigate the medical device consulting difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates can help.

 

Our network of over 500 compliance consulting Experts are industry professionals & FDA, MHRA & EMA veterans. This allows Regulatory Compliance Associates to handle both simple and complex regulatory compliance challenges within medical device consulting scenarios.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates is globally known for quality assurance services, including quality system assessments, strategy, implementations, and quality metrics to ensure continuous improvement. Each Regulatory Compliance Associates medical device consultant is a quality expert with experience spanning major corporations and start-ups. RCA’s quality assurance services experts know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years of experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges has a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters, and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate demands of remediation services with insight and the clear advantage of our medical device consulting expertise. Our deep industry experience makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation services space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or a project, Regulatory Compliance Associates medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® due diligence consulting can deliver your project on time, and on budget, and you’re never embroiled in a costly mistake. 

 

Our medical device consulting Experts are industry Experts who are here to provide the unique insight you need before an M&A deal, through a staffing crisis, and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

Medical Device TestingRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,000+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

The Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, recently testified in front of a Senate Appropriations subcommittee about core programs for the 2025 budget process. Executives at FDA are asking for a $341 million increase in the annual budget (currently proposed at $7.22 billion) compared to the previously approved FY 2024 budget.

 

Drug Shortage

 

One topic that received significant interest was drug shortages. Dr. Califf confirmed there are still over 200 drugs classified as in shortage. FDA has requested over $12 million to help rectify the problem and bring greater predictability to supply chain problems. Additionally, the ability to clarify pharmaceutical manufacturing problems that may arise appears to be a priority to FDA.

 

Regulatory Affairs

 

The Office of Regulatory Affairs (FDA ORA) has asked for an additional $2.7 million to be added to the proposed budget. Specifically, ten new full-time employees are proposed as headcount to address issues with both drug shortages and problems inside the supply chain. $3 million is specifically proposed to recruit new FDA inspection resources who can help identify these types of scenarios in advance during routine FDA inspections.

 

Further, continued growth in regulatory applications for both medical device manufacturing and biologic manufacturing facilities was mentioned as critical to keep pace with the industry’s need for FDA approval inspections. For life science industry employees, the slowdown in FDA inspections has had mixed reactions.

 

Michael Rogers, associate commissioner for regulatory affairs at the FDA’s Office of Regulatory Affairs, has also recently commented about the need for more FDA auditors due to investigators who have recently retired. According to Rogers, FDA investigators “have been underrecognized and underappreciated”, which may have led to attrition over time at the agency.

 

Avian Influenza Virus

 

Dr. Califf continued the discussion with lawmakers about the potential dangers of avian influenza (or bird flu) and vaccine production. Commentary revolved around how prepared the United States government is in responding to virus mutations if bird flu could spread to humans. Further, Dr. Califf elaborated on how investments in personal protective equipment (PPE) & funding for vaccine manufacturing could help the potential problem.

 

Finally, short-term solutions focused on the safety of dairy workers if the virus infected the U.S. milk supply, and new research options to study how quickly the avian influenza virus may evolve. 

 

IT Infrastructure

 

Finally, FDA has requested over $8 million to improve critical infrastructure and upgrade technology across the agency. The goal is to modernize many of the legacy workflows the regulatory agency uses and increase the analytical potential of data analysis.

 

The entire presentation can be found at this link

 

Pharmaceutical Consultant & Pharma Consulting Services

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in the complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

food and drug administrationRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

continuous manufacturingThe U.S. Food and Drug Administration (FDA) recently updated its pharmaceutical manufacturing guidance on Continuous Manufacturing (CM), including elaborating on established industry best practices.

 

Examples of new insights provided by FDA include clarification of the differences between continuous manufacturing modes and manufacturing approaches. The intended purpose behind the guidance is to continue industry harmonization efforts between ICH guidance and FDA regulatory & statutory requirements.

 

Continuous Manufacturing

 

Continuous manufacturing involves the process of uninterrupted materials being steadily added into the manufacturing process. The in-process ingredients are then manufactured and simultaneously developed into output materials during manufacturing. The updated FDA guidance focuses on facets of a continuous manufacturing system where multiple steps of operation are connected as continuous flow manufacturing.

 

The intended seamless procedure is considered by many industry experts as more efficient and helps reduce human error. By comparison, batch manufacturing lines may not use the same types of automated monitoring nor leverage as many predictive maintenance data points.

 

Factors of Production

 

The FDA guidance provides a deeper explanation of the underlying continuous manufacturing factors of production. A description of these characteristics by the Agency expands upon continuous flow production themes, including types of technology, options for dosage form, or molecule type.

 

Topics that are broadly applicable to a continuous production system and batch manufacturing are not included in the updated guidance scope. FDA recommends to the reader to revisit other existing ICH Q7 guidance as needed and appropriate for the medical manufacturer.

 

Control Strategy

 

Continued process performance and product quality are two primary elements described in the scientific approach to continuous manufacturing. State of control relies on the continuous production process and unique parameters (e.g. process parameters, quality attributes, etc.) that are designed to stay within an appropriate pre-set range.

 

Further, the guidance specifically calls out the importance of identifying the root cause of drift. FDA continuous manufacturing examples highlighted for employees to closely monitor include variation of inputs, equipment fatigue, and aging of materials.

 

Process Dynamics

 

Understanding transient events and the various impacts they can have on the continuous production system is a critical facet of FDA Control Strategy. Further, the FDA guidance elaborates that this includes transient events that are both planned (e.g., process start-up, process shutdown or a manufacturing pause) and unplanned (e.g. production disturbance).

 

Residence Time Distribution (RTD)

 

One key takeaway from the FDA guidance for industry is understanding how process dynamics are characterized when output material quality is affected. Additionally, using measures like residence time distribution can help medical manufacturers differentiate between the time available for material transport and transformation. 

 

This type of quality metric strategy is specific to the continuous manufacturing process an often includes:

 

  • Product composition
  • Product formulation
  • Material properties
  • Equipment design
  • Equipment configuration

 

Operating Range

 

Each planned operating range should be based on the process dynamics and characterized by the planned over the planned ranges and anticipated input. Further, the FDA clearly states that material variability should use scientifically justified approaches for measuring quality against process dynamics that illustrate the variation during material transport and transformation.

 

Material Characterization

 

The FDA guidance goes on to list material feeding, process dynamics and output material quality as crucial continuous manufacturing elements that negatively impact material characterization. The FDA guidance lists a materials characterization facility as important to increasing production quality. Finally, realizing the predictability of material attribute variability on process performance and product quality is significant to the control strategy.

 

Solid Dosage Form

 

While analyzing the continuous manufacturing material flow process in a solid dosage form, the FDA guidance lists the following considerations that can impact powder feeding:

 

  • Particle size
  • Cohesiveness
  • Adhesiveness
  • Hygroscopicity
  • Static charge
  • Surface area of drug substances and excipients

 

Chemically Synthesized

 

While analyzing the material flow process in a chemically synthesized drug substance, the continuous manufacturing FDA guidance lists the following considerations that can impact flow properties:

 

  • Viscosity
  • Concentration
  • Multi-phase feed

 

Monoclonal Antibody

 

While analyzing the material flow process in a therapeutic protein (e.g. monoclonal antibody) substance, the FDA guidance lists the following continuous manufacturing considerations that can impact cell culture performance, process performance, or process consistency:

 

  • Lot-to-lot variability
  • Cell culture media
  • Different types of feed components

 

System Integration

 

The FDA guidance goes into depth about integrated systems characteristics and how equipment design can influence continuous manufacturing performance:

 

  • Design configuration
    • Maximum run time compatibility
    • Parts geometry impacting transformation
    • Integration and transfer steps
  • Design interface
    • Surge tanks
    • Mass flow rate
  • Material diversion and sampling
    • Diverter valve
    • Sampling probe
    • Material flow
    • Material transformation

 

The guidance continues to elaborate on equipment selection and how the equipment design, if executed properly, can help with process simplification.

 

Process Monitoring

 

Process monitoring and maintaining a state of control during production increases the understanding of real-time system performance. The FDA guidance states that these common approaches to process monitoring and control are also applicable to continuous manufacturing:

 

  • Established target setpoints
  • Established control limits
  • Design space
  • Measurement specifications

 

Process Analytical Technology

 

The FDA guidance also elaborates on why process analytical technology is suitable for continuous manufacturing. Examples provided by the agency for industry employees include:

 

  • In-line ultraviolet (UV) flow cells
  • Monitoring therapeutic protein concentration
  • In-line near-infrared spectroscopy
  • Assessing blend uniformity or water content
  • High-performance liquid chromatography
  • Monitoring the conversion of chemical reactions

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

continuous manufacturingRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Click now to watch Regulatory Compliance Associates® Dr. Stephen Coulter explain how design controls and risk management play an intricate role in the Waterfall methodology:

 

 

The Waterfall methodology incorporates the usage of FDA design controls into the medical device design process. It serves as the primary connection between quality system requirements (QSR) and current good manufacturing practices (CGMP).

 

Waterfall Method

 

Conceptually, the FDA Waterfall model is designed to provide engineers with the flexibility to mitigate product risk, meet regulatory compliance and satisfy customer needs. It is a sequential process based on the quality assurance and medical device engineering principles listed in 21 CFR 820. The methodology itself is conceptualized in the image below from the Medical Device Bureau of Health Canada. 

 

Waterfall Development

 

To increase risk mitigation during the Waterfall methodology, both risk management & design controls are considered. They often become integrated processes during Waterfall product development. Many unique tools that medical device engineers use to define requirements & meet user needs are shared across these processes, even though each is based on a separate standard.

 

While design controls for FDA approval are referred to in 21 CFR 820, medical device risk management is internationally associated with ISO 14971. Three critical elements of risk mitigation strategies clearly focus on avoiding risk during product development:

 

  • Evaluating an associated risk
  • Controlling an evaluated risk
  • Monitoring risk control effectiveness overall

 

Input Requirements

 

The success of the Waterfall development method depends on early research & assessments conducted about input requirements that include strategic risk. Further, spending time documenting the inputs of user interface, user stories and product epics can help increase positive outcomes and reduce requirement risk overall.  Finally, any inconsistencies during the waterfall methodology between the proposed design & input requirements can be corrected across stages. This aligns with one of the primary motivations behind FDA originally developing 21 CFR 820 (e.g. helping medical device manufacturers find design deficiencies earlier in the process).

 

Risk Management

 

By starting the Waterfall process with this end state in mind, design inputs are more likely to pass failure testing & become a manufacturing output. This risk management strategy during a Waterfall project can begin with identifying the publicly known risks of competitive products. Second, the team is challenged to investigate if similar hazards could be associated with your medical device. When working with a Regulatory Compliance Associates risk management consultant, our clients are reassured that Waterfall development should detail how hazards can impact user needs & potential customers.

 

For example, design inputs should consider current regulations and global standards early in the waterfall process. This helps incorporate a risk management perspective even before verification and validation testing begins. Intended uses should consider predicate devices and if any causes for recalls are related to design, materials, or software. 

 

Waterfall Approach

 

So, does this mean risk management & design controls are connected in the waterfall approach? And if they are, how important is one over the other when leading to marketing approval or regulatory compliance? This process is often measured against a combination of factors, including:

 

  • Regulations & standards for clinical approval
  • Risk class of medical device being manufactured
  • Regulatory body reviewing the marketing submission

 

Enterprise risk management would consider all three of these factors individually and in combination when considering how to eliminate systemic risk. The Waterfall project management team can also use various tools and techniques while developing the risk management plan. These risk identification tools include conducting a risk analysis, performing an FMEA, and charting risk tolerance. 

 

Risk Analysis

 

Existing regulations & standards offer various types of risk tools that can be incorporated into design controls. This can include identifying risk levels and creating severity charts during the user needs & design inputs stages. Additionally, each new product will have different hazards and risk tolerance levels associated with the target patient. Being able to analyze the problem, control the problem, and mitigate the risk is essential to define in your risk analysis. Challenge yourself to reduce and identify hazards by analyzing the known data as much as possible.

 

FMEA

 

Failure Mode and Effects Analysis (FMEA) is a controlled technique to detect & concentrate on budding trouble. Each failure is commonly assigned a rating based on the negative effect it may cause. The Waterfall process would then take each rating and project how the marketplace, healthcare systems, or patients can be impacted. FMEAs are one of many risk mitigation tools that can help your team identify the hazards of your severity chart. Each charted hazard is established based on the severe nature of the hazard to the user and project requirements for design control.

 

Risk Tolerance

 

Further, after the severity is defined, all known or projected hazards can be developed into a risk tolerance chart. The risk tolerance chart can then be shared cross-functionally across the team to help everyone understand which design steps can increase user risk. One of the benefits of a risk tolerance chart is being able to show data visualization. The design team should consider how design controls and user needs can reduce the hazard’s impact. Finally, a waterfall chart could also project the negative consequences of adverse events and what the estimated cumulative impact might be during a product crisis scenario.

 

Risk Management Summary

 

Finally, once your team has evaluated the risks and decided on precautions, a risk management summary is developed. It may include involves multiple failure mode analysis types (e.g. product, process, etc.) and risk ratings. These initial ratings are typically based on the types of failures and the severity of the failure itself. Ranges can also be given to determine the risk management strategy and what is the acceptable level of product risk (e.g. high, medium, low).

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

About Regulatory Compliance Associaties

 

Regulatory Compliance Associates (RCA® ) provides pharmaceutical supply chain consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, supply chain, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

RCA Pharmaceutical Supply Chain Consulting Services

 

The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:

 

Assessments 

 

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

 

Our range of compliance consulting services includes:

 

  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.

 

Audits 

 

Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:

 

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

 

Regulatory Agency Response 

 

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

 

  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans

 

Preparation, Training, and Inspection Readiness 

 

Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:

 

  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations

 

Data Integrity

 

Training:

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting:

 

  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

cGMP Consulting

 

Maintaining data integrity is an important part of ensuring the manufacturing quality of your pharmaceutical. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

 

In a time when compromised data has become a common concern among businesses in the life science field, it’s become more critical than ever to maintain healthy practices concerning data storage and release. Medical device companies of all sizes and types need to trust their data’s integrity, which is why thousands of businesses have turned to Regulatory Compliance Associates® for GMP quality compliance services.

 

With a team of more than 500 industry experts and seasoned veterans of the FDA, we know what it takes to adhere to the standards of global regulatory bodies. We offer the expertise needed to help your business stay within cGMP and preserve your data’s integrity. Our array of training and consulting services will ensure that your customers’ trust in your brand is well-placed.

 

GMP Quality Compliance Services

 

Training

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting

 

  • cGMP Consulting
  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with the execution of Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of your medical device—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

Manufacturing Processes

 

Our comprehensive evaluations will identify GMP pharmaceutical practices that consistently yield a sustainable return on investment. We will help you identify opportunities for:

 

  • Reducing Set-Up Times
  • Increasing Throughput
  • Reducing Inventory Levels
  • Lab Efficiency Improvements
  • Scrap and Waste Reduction
  • Cycle Time Compression
  • Capacity Creation
  • Process Automation
  • Cost Reduction

 

Manufacturing Optimization

 

Regulatory Compliance Associates provides the following manufacturing optimization services:

 

  • Program Analysis
  • Process Optimization through Engineering Studies
  • Statistical Process Control
  • Lean Innovative Product / Process Solutions
  • Value Stream Mapping
  • Kaizen Events
  • Design for Six Sigma
  • Inventive Problem Solving

 

Automated Industrial Services

 

Regulatory Compliance Associates  provides manufacturing automation consultants with deep industry experience including:

 

  • Validation Master Plan
  • Development of Validation Documentation
  • Validation Services
  • Risk Assessments

 

Factory Automation

 

Regulatory Compliance Associates helps clients develop innovative factory automation via design strategy and hands-on validation support. We ensure that updating manufacturing facilities will continue to meet all regulatory and client requirements, without an adverse impact on the finished product.

 

  • HVAC Systems and Associated Controllers
  • Medical Gas Systems
  • Plant and Pure Steam Systems
  • Water Systems including USP, RO / DI, and WFI
  • Compressed Air Systems
  • Controlled Environments

 

Pharmaceutical Contract Manufacturing

 

When you choose Regulatory Compliance Associates as your pharmaceutical manufacturing consultant, you’ll have the support of validating every contract manufacturer. RCA provides the combined skills and knowledge of more than 500 pharmaceutical and medical device experts who are experienced at working on the front lines of regulatory requirements. RCA clients benefit as these solutions move suppliers toward a culture of quality, from startups to Fortune 100 international enterprises.

 

Quality Management System

 

To create a positive change in the lives of patients counting on the availability of your product, you need to recognize the regulatory pathways of drug manufacturing companies that are ahead of you. Further, this includes the evolving technical development of your quality management system. When you work with us, you get a team that tailors its services to the comprehensive needs of your company. And that’s how you can be assured you’ll always receive the support you need to implement corrective action wherever it may be needed.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

About Regulatory Compliance Associates

 

life science consultantsRegulatory Compliance Associates (RCA) provides life science consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. Our life science consultants are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA)® has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

 

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • CDMO partners looking for aseptic processing or regulatory compliance support 
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge when it comes to outsourcing regulatory services. We offer the following four regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products
  • Regulatory Affairs Outsourcing

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and regulatory compliance services necessary to guide you in quality compliance.

 

  • Assessments
  • Internal Audit or Compliance Audit
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality life science consultants with experience spanning major corporations and start-ups. Our clinical evaluation consultants know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious remediation services situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute.

 

We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA® can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About RCA’s Medical Device Consulting Services

 

The regulatory process surrounding the medical device industry involves strict adherence to pre/post market compliance throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA®‘s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 life science consultants — including former FDA officials and other leaders in the field of medical device regulation — will work hand-in-hand with your company. RCA’s medical device consultant process includes creating a customized quality assurance and regulatory compliance approach tailored to your products & regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, FDA 483 support, import bans, or consent decrees. Each RCA medical devices advisor has a background of diverse regulatory expertise across a variety of disease states and medical fields. 

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

 

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® ‘s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and/or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights that increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

 

Our network of over 500 FDA, Health Canada & MHRA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

  • Gap Assessments
  • Internal Audits
  • Biocompatibility Testing
  • Employee Training
  • Notified Body Response

 

Quality Assurance

 

Regulatory Compliance Associates Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA®, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Services

 

Regulatory Compliance Associates is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve remediation services challenges. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters, and Consent Decrees.

 

Our ISO 13485 consultants often go beyond the initial response by helping companies successfully execute their action plans & develop an improved compliance culture. RCA’s medical device consulting team can help you move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation consulting with insight and the clear advantage of our unique expertise. Our cGMP training programs make partnering with RCA® Inc. a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates life science consultants can help ensure a successful mix of people and products so your project is on time, on budget, and you’re never embroiled in a costly mistake.

 

Our 500 industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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