Tag: quality consultants

Click now to listen to RCA’s Susan Schniepp and Steven Lynn, in this RCA Radio audio update:

 

Personalized Medicine

 

Software as medical device (SaMD) continues to emerge in consumer products, including diabetes and sleep management. When it comes to FDA cybersecurity, every device developer knows the ecosystem is more likely to be wifi-connected than ever before. Cyber awareness involves using design controls to consider a variety of consumer SaMD applications & how they connect to smartphone operating systems and open network solutions. By scaling efficacy technology, or personalized medicine, developers are addressing a rapidly growing segment of healthcare treatment.  

 

FDA Cybersecurity

 

How can regulatory compliance help protect consumers from hackers when forwarding patient info between sources is involved? During a risk assessment, a SaMD consultant might end up looking at every step between the health system provider and convenience of not visiting a clinical environment. Further, as industry leaders who understand how technology can increase the speed of personalized medicine to market, what types of cyber awareness becomes more critical to protecting patients?

 

Home Dialysis

 

One SaMD cybersecurity focus Schniepp has already identified is in the Home Dialysis industry. Medical device manufacturers are continuing to evolve with the demand for smaller prototype devices in general, which may enhance cyber convenience becoming a competitive advantage. However, the commercial cyber threat is permanent and even the largest organizations in the dialysis industry can be a target. 

 

Combination Products

 

Lynn agrees & understands that an FDA combination product strategy will continue innovation by means of software and drug delivery. This fundamental mindset change requires extending the definition of “users” of these connected medical devices. It includes patients and HCPs — but also FDA inspection roles needed during during regulatory compliance (e.g. biomedical engineers, IT engineers).

 

Fixed Dose Combination

 

Any combination device would include cyber awareness practices between medical devices & connected facilities that demonstrate and prove trust. Do the relationships between healthcare infrastructure increase or decrease exposure to disruption? Further, where could any attack surface breach trust and cause harm to the patent (e.g. disrupting a patient dosing device). Cyber awareness understands that intended use of the device must also address the perspective of an unwanted attacker.

 

Regulatory Compliance

 

Lynn & Schniepp both agree on one topic: patient compliance. Any type of medical device software that increases patient adherence during a healthcare routine will be applauded by FDA consultants. FDA SaMD guidance lists the ISO standards and QMS regulations needed for the submission. Accelerating the intended use through increased compliance is a regulatory strategy that can be presented via clinical evidence.   

 

About Susan Schniepp

 

Regulatory Compliance Associates® Distinguished Fellow and the Parenteral Drug Association® (PDA) Chair of Board of Directors, Susan Schniepp, will be presenting a tech talk at INTERPHEX® in April 2023 where you can learn about contamination control strategy, how to identify and assess risk, prepare mitigation pathways, and defining preventive actions associated with contamination in sterile product manufacturing.

 

Sue is the knowledge leader for RCA® and is Chair of the Parenteral Drug Association (PDA) Board of Directors. Sue’s background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.

 

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 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 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.

 

  • 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, 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 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 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

 

cyber consultingRegulatory 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 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. 

 

Data integrity is the reliability, consistency, and accuracy of data at rest and in transit. Quality data adheres to several standards, beginning with integrity, confidentiality and availability.

 

Data integrity is a process to ensure consistent and accurate data over its life cycle. Requirements specify that data records need to be attributable, legible, contemporaneous, original, and accurate (ALCOA). In addition to the ALCOA, there is ALCOA+ which also requires data to be complete, consistent, enduring, and available.

 

Good Practices for Data Management and Integrity

 

Compromised data can lead to poor business decisions. Any decisions based on inaccurate data are suspect during inspections. To ensure the integrity of your company’s data:

 

  • Implement access controls. Locking and securing sensitive records and restricting unauthorized users from accessing data can reduce loss and corruption. 
  • Make backups. Once lost, raw data is irreplaceable. Backups must include original, raw data creates a duplicate in an alternate location. 
  • Validate the data. Automate digital validation by organizing and filtering data using scripts. Validation checks the quality of the data to be secure, meaningful and correct. 
  • Have a quality system in place. Having a quality system in place and ensuring procedures can be completed on- or off-site will help solve any issues. 
  • Think through changes. If you’re going to change processes to adapt to a more virtual environment where employees work from home, think about all necessary steps or procedures.
  • Organize files and systems. Systemically arranging your files helps you easily pass off or explain data to others such as auditors and inspectors.
  • Validate input. You can use input validation to block cyberattacks, such as structured query language (SQL) injection prevention. Checking input at the time it is recorded is crucial.

 


Does your team need help with Data Integrity? Talk to our Experts→


 

New Guidance From the Food and Drug Administration (FDA)

 

The best way to maintain a supply of safe and effective products and prevent a drug shortage is to comply with data integrity concepts to prevent batch rejection/recall and monitor sites and stay up to date on FDA guidelines. You can do this by: 

 

  • Reviewing the staff manual guide. This guide covers FDA internal procedures for requesting records in advance of or in place of a drug inspection. 
  • Ensuring your company has a quality culture. Complications during the COVID-19 pandemic have only made processes more complicated, so establishing procedures around quality culture can help deter issues. 
  • Building quality into your operations: make sure you have a strong training program and it’s importance to the organization and the product.
  • Having a solid risk management plan. A solid risk management strategy can save you money, time, and unnecessary manufacturing disruptions and establish a process to deal with potential risks that may arise.

 

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

 

pharmaceutical consultantsRegulatory 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. 

In the life science industry, 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 or drug is sent to market. At Regulatory Compliance Associates (RCA), we offer you the quality assurance services you need to monitor these quality processes and ensure quality compliance every step of the way.

 

RCA’s quality assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

Quality Consulting

 

The life science industry faces increased challenges as companies navigate the world of QA with fewer personnel. Strategic leadership is necessary for creating a quality management system, but this leadership requires a dedicated staff that many companies can’t afford. Outsourced quality support services are an ideal solution to this challenge.

 

Regulatory Compliance Associates can meet a variety of quality assurance services throughout your company’s product life cycle. Our quality consulting Experts provide trusted expertise while saving the money of hiring in-house staff. RCA can assist in situations such as:

 

  • Short-term augmentation due to transitions in staff:
    • Quality Assurance Consultant
    • Quality Control Consultant
    • Quality Engineering Consultant
    • Quality Management Consultant
    • Quality Systems Consultant
    • Software QA Consultant
    • Software Quality Assurance Consultant
  • Special projects
  • Strategic management and leadership of QA duties
  • New companies in need of QA insights
  • Root cause investigation
  • Corrective and preventive action support
  • Complaint handling
  • Recall management

 

Quality is something our software quality assurance consultants are experts at with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this quality assurance services knowledge to your quality engineering team.

 

QA Services

 

  • Quality Assurance Consultants – Interim Management, staff augmentation, or outsourcing quality and regulatory management has become increasingly common in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies.  Business consultant needs may vary greatly depending on the lifecycle of the organization, and RCA’s quality consultants are up to the task. 
  • QA Audit – Virtual gap assessments can assist your team in advance for an upcoming QA inspection by a notified body. These proactive organizations turn to RCA for management consulting Experts who can describe exactly what a notified body looks for.
  • Quality Assurance in Software Testing – Cybersecurity is becoming more essential to our industry based on updated FDA cybersecurity guidance. Pharmaceutical manufacturers partner with RCA for their cybersecurity FDA strategy and how to stay ahead of hackers. 

 

QA Process

 

Early in a company’s lifecycle, strategic leadership is needed for​ ​product filings, regulatory pathways, manufacturing setup, and quality management systems creation. As the company matures, QA planning often transitions to a continuous improvement stage when leveraging quality assurance services makes sense.

 

  • Total Quality Assurance
    • Quality Assurance Methodologies
    • QA Procedures
    • Project QA
    • Product QA
    • Supplier QA
    • Digital QA
    • Agile QA

 

Outsourcing QA management can often provide a more strategic perspective when you’re challenged with changing quality control in engineering teams. The pharmaceutical quality experts of Regulatory Compliance Associates bring a wealth of quality assurance management needed to help you cut cost via unique QA methodologies.

 

QA Planning

 

  • Quality Control Audit
    • QA Procedures
    • QA Reporting
    • QA Responsibility
    • SOP Quality Control
  • QA Best Practices
    • QA Programmer
    • QA Project Manager
    • QA Software Tester
    • SQA Tester
    • Software QA Analyst
    • Software Quality Analyst
  • QA Testing Services
    • Standard Quality Control
    • Quality Control Tester
    • Quality Assurance Analyst
    • Data Quality Analyst

 

Software QA

 

  • Software QA Outsourcing
    • Agile Quality Management
    • Web Quality Assurance
  • Software Quality Control
    • Quality System Automation Using Software
    • Quality Systems Implementation
    • Quality System Remediation / Improvement
  • Quality Control Procedures
    • Computerized System Validation Standard Operating Procedure (SOP) – Our computer validation experts and software engineers have extensive experience with the GAMP5 validation model. RCA’s quality assurance services Experts can ensure that you have the appropriate level of documentation.
    • Risk Management ICH Q9 – RCA’s business management consultant team can provide you with the tools needed to implement or remediate your quality systems. Every RCA® quality technical consultant understands current industry standards and how to train your personnel.

 

QA Teams

 

  • Corrective and Preventive Action (CAPA) and Complaint Systems – We manage the implementation and remediation of CAPA systems and Complaint Handling Systems.
  • 21 CFR Part 210 and 211
  • Quality Control Assurance
    • EU Good Manufacturing Practice (GMP)
    • Quality Assurance Best Practices
  • QA Testing Process
    • Performing Quality Control
    • QA Workflow
  • Quality Culture Guidelines
    • QA process
    • QA Tester
    • QA Analyst
    • QA Management
  • Laboratory Support
    • SOP Development
    • Method Transfer
    • Method Validation
    • Data QA

 

Medical Device Single Audit Program (MDSAP)

 

Regulatory Compliance Associates will help you navigate required activities as you prepare for an MDSAP audit. We offer MDSAP-based medical device quality consultant services to support you in the following areas:

 

  • Gap assessments to evaluate MDSAP requirement compliance
  • System improvements to assist with the transition to MDSAP
  • Preparation assistance and mock audits for the rigorous MDSAP audit process

 

ISO 13485

 

When you face restrictive deadlines to meet ISO 13485 requirements, Regulatory Compliance Associates quality assurance specialists are here. Our quality management system consultant team offers the following quality assurance services, including:

 

  • Quality system transition and implementation
  • Quality system gap assessments
  • Readiness audits
  • Risk management (ISO 14971)
  • Data Integrity

 

About Regulatory Compliance Associates

 

Quality Assurance ServicesRegulatory 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, 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 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. 

To learn more about quality control and data integrity, you need to understand what these terms mean and how they can affect your company.

 

What Is Quality Control and Data Integrity?

 

The Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments document from PICS offers perhaps the most comprehensive explanation of what a quality culture is. According to that document, this type of culture is a work environment that is open and transparent, allowing team members to fully and openly communicate mistakes and failures. This open culture is also a work environment where there are processes and structures that allow information about mistakes and problems to flow between team members at different levels.

 

Why Quality Culture?

 

Quality culture and its importance to the World Health Organization, MHRA and PICS recognizes that data quality is reliant on type of workplace. An organization that punishes team members who come forward with mistakes or issues is likely to have fewer reportable issues and less transparency, which can mean less accurate data. By allowing team members to speak freely and permitting the information to flow to different tiers of the organization, you’ll ensure that data can be accurately collected and acted upon.

 

Improving Organizational Quality Culture and Data Integrity through Risk Management

 

If you would like to create a quality culture, your organization can take several steps, including:

  • Creating a quality risk management plan: A written quality risk management plan should include your potential risks and a detailed plan on how to address problems and mistakes. This plan should make it clear that every team member is part of the solution and can report problems without risk of retaliation.
  • Evaluating your risks: Run an organization-wide audit to evaluate which risks could negatively impact product quality. As you start to write your quality risk management plan, begin by evaluating the risks that could impact your product. Could a supplier issue compromise the product? What other problems have arisen in the past or affected others in your industry?
  • Having a remediation plan: Create a written plan on what to do if something happens. How will an issue be reported? Once an issue is reported, what will the next steps be? How can you begin the remediation process?
  • Maintaining your plans as living documents: The goal of a quality risk management plan isn’t to create a document that sits on a computer. Present the document to your team and use it every day. Add to the document as new challenges come to light, and encourage your team to abide by the plan.

 

How We Can Help

 

A quality culture will help you pave the way for success because you’ll be enjoying better data. When you need to submit to global regulatory agencies, having more robust data can also help.

 

While having data integrity and good metrics is a crucial factor for biologics, medical device, pharmaceutical, compounding pharmacy and other organizations, an open quality culture is also important. In addition, it will help you to notice issues and address them in a timely fashion as well as enable you to plan what to do when problems arise.

 

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

 

quality controlRegulatory 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. 

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