Category: Biologics

The application date of May 26, 2022, for the EU In-Vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) has created a huge challenge for IVD medical device firms planning to introduce or continue to market their IVD products to any of the European Union Member States. 

 

One of the biggest changes from IVDD to IVDR is the move from list-based IVD device classifications to a rule-based IVD medical device classification resulting in 4 new device classes: class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body involvement.

 


Need help with your transition to the EU IVDR? Contact Us Now →


Photo of Seyed Khorashahi
Seyed Khorashahi, Executive Vice President of Medical Device and CTO

 

“The combination of major changes to the IVDR device classification resulting in 3-fold increase in IVD medical devices requiring notified body involvement and lack of adequate IVDR designated notified bodies has created a huge bottle neck to getting ready for the EU IVDR by the application date of the EU IVDR.” says Seyed Khorashahi, Executive Vice President of Medical Device and CTO of Regulatory Compliance Associates Inc.® (“RCA”).

 

This change alone would result in a huge number of medical devices requiring Notified Body involvement. It is estimated this quantity of medical device products will increase from 20% under MDD to approximately 80% under IVDR.  As of this writing, there are only 4 IVDR designated Notified Bodies, which visibly increases the number of goods our clients must submit. 

 

Photo of Lisa Michels
Lisa Michels, General Counsel

 “Right now, we’re partnering with global clients that have both a small and sizable product portfolio of In-Vitro Diagnostic Devices, and they are at different stages in their IVDR implementation efforts,” says Lisa Michels, General Counsel for Regulatory Compliance Associates® Inc. (RCA). “Proactive strategic planning and effective resource allocation are critical for the timely execution and implementation of a comprehensive IVDR Implementation Plan. IVDR manufacturers must consider and prepare for potential delays such as scheduling bottlenecks for Notified Body Conformity Assessment activities, which may directly or indirectly impact their planned commercialization efforts for existing and/or new IVDR products. IVDR manufacturers must establish contingency plans to mitigate some of these potential challenges in this new regulatory environment under the EU IVDR since all IVDR manufacturers are facing the same task.”

 

Additional nuances from IVDD to IVDR are based on a medical device lifecycle approach and include:

 

  • Requirements for medical device manufacturers to establish and demonstrate effective quality management systems (QMS)
  • More stringent requirements for clinical evidence demonstrating conformity.
  • New requirements for post-market performance monitoring and reporting
  • Greater supply chain oversight and device traceability, including giving the notified bodies discretionary authority to supplier audits and subcontractor compliance.

 

The transition from IVDD to IVDR can be a time-consuming process, and many companies are still in the process of regulatory transition. 

 

“It’s time-sensitive because our clients are learning how to deal with their current notified body, and if they are still the correct partner to work with” continued Khorashahi. “We initially start with a strategic approach to plan their regulatory strategy of current IVD medical devices in the field and their IVDD certificate expiration date to prioritize the products that need immediate attention. “Each of the IVD medical devices has to be reclassified according to the new IVDR device classification rules.”

 

If you are a small to medium size company and have not already started your transition, now may be the opportune time to engage with a strategic partner like RCA to prepare for the IVDR deadline.

 

“Timely compliance to the IVDR requires a dedicated team of subject matter experts to properly implement and execute the compliance deliverables as laid out in your IVDR Implementation Plan” continued Michels. “These deliverables may require extensive updates to a manufacturer’s existing Quality Management System (QMS), technical documentation, and/or establishing or enhancing a manufacturer’s body of objective evidence of clinical performance validation with a defined blueprint to address the product lifecycle.”

 

IVDR

Your organization has a better chance of a successful transition by engaging subject matter experts like RCA who have an intimate familiarity with the planning and implementation of IVDR.

 

“Our experts can help you identify the intended purpose and the inherent risks associate with your devices, determine the device classification, and help create technical documentation in compliance with IVD regulation 2017/746.:es” Khorashahi divulges.

 

More robust procedures for post-market surveillance and post-market performance follow up must be put in place to successfully transition.

 

“RCA has the subject matter expertise, experience, and dedicated resources available to assist our clients with the seemingly daunting task of ensuring timely IVDR compliance prior to the fast-approaching deadline. Our proven capability is what clients find to be of most value in the selection and utilization of a regulatory compliance consulting firm like RCA.” replied Michels.

 

About RCA’s Medical Device 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 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

 

IVDR 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. 

 

What should you do if you are having trouble executing your design protocols? 

Listen to this highlight from RCA Radio where Walter Mason explains what needs to be done if you have troubles executing your design protocols even after training.

 

 

Listen to the entire episode where we take an in-depth look at protocols for biologics and their importance. RCA Radio Episode 13.

 

What can you do?

  • Go to the developer and let them know that it is not working for you
  • Talk through the design protocols in general
  • Procede step-by-step through the design protocols process
  • Look back at the FDA guidance documents
  • Get feedback on your design protocols
  • Implement changes in your training or to the protocol itself

 

About RCA’s Biotech Consulting Services

 

Regulatory Compliance Associates® can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics consultants & consulting services include:

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®  backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

 

  • Preclinical & CMC Consulting
    • FDA Meetings & Briefing Package Assistance
    • Clinical Trial Applications
    • Marketing Applications
    • Medical Writing
  • Lifecycle Management
    • Combination Products
  • Submission Planning & Strategic Support
    • eCTD Publishing & Submissions
  • Strategic Consulting & Intelligence
    • Risk Management Plan
  • US Agent
  • Project Management Support
    • Data Integrity
  • Clinical Development Support
    • Clinical Research Organization (CRO) Sourcing
  • Analytical Development Support
    • Bioassay Design & Validation
    • Immunoassay Support
    • Statistical Analysis & Specification Setting

 

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 biologics consultants preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® biotech consulting global team can help.

 

  • Assessments
    • Current Good Manufacturing Practice (cGMP)
    • Corrective & Preventive Action (CAPA), Investigations & Deviations
    • Facility & Maintenance 
    • Data Integrity
    • Quality System Gap Assessment
    • Quality Metrics
  • Audits
    • Supplier Audits
    • CRO Audits
    • cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
    • cGLP Audits
    • Good Clinical Practices
  • Preparation, Training & Inspection Readiness
    • cGMP Fundamentals (Annual Training Required by Regulations)
    • Quality System Regulation
    • Risk Management
    • Investigations, Deviations & CAPA & Root Cause Analysis
    • Validation & Technology Transfer
    • Purchasing Controls & Supplier Management
    • Document Management & Change Control
    • Audit Readiness
    • Quality Culture & Management Responsibility
    • Data Integrity & 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

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics. Our biologics consultants goal is to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have 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.

 

  • Quality Management System Implementation
  • SOP Development
  • Document Control Systems
  • Change Control
  • Laboratory Operations & Control

 

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 complex regulatory services regulatory challenges. With a proven track record of success, Regulatory Compliance Associates® biologics consultants have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
    • 483 Response & Remediation
    • Warning Letter Response & Remediation
    • Consent Decree Response & Remediation
    • Oversight Services
  • Consulting
    • Comprehensive Audits
    • Remediation Plan Development & Implementation
  • Manufacturing Support
    • Re-validation of Existing Equipment & Processes
    • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility 
    • Facility Improvements (Aging Facilities) 

 

Strategic Consulting

 

Whether it’s a corporate needs analysis, corporate growth / transformation strategy or due diligence / acquisition, Regulatory Compliance Associates®  worldwide biotech consulting experience can help ensure a successful mix of top-notch advice and people so your engagement is on time, on budget, and you’re never embroiled in a costly mistake.

 

  • Portfolio Management
  • Mergers & Acquisitions / Due Diligence
  • Staffing Support

 

Biostatistics

 

At Regulatory Compliance Associates, we recognize that biostatistics continues to change life science consulting one project at a time. Our biostatistics consultant Experts can help with both your internal or external clinical study and medical research needs.

 

RCA biostatisticians will create a custom scope of work based on the applicable statistical tests and predictive techniques that increase regulatory compliance. In fact, our statistical consulting team approach to clinical study design and clinical research provides Regulatory Compliance Associates clients a true competitive advantage during product development and commercialization. 

 

Our biostatistics consulting services include:

 

  • Clinical research
  • Medical research
  • Epidemiological research
  • Disease occurrence research
  • Disorder prevalence research
  • Data safety monitoring
  • Adverse event research

 

Regulatory Compliance Associates healthcare consulting Experts can provide quantitative analysis that propels your commercialization projects faster and more accurately. Our statistical consulting Experts can provide deep insights into the regulatory compliance process of what can help you with your regulatory submission.

 

Biostatistics is more than just getting your white paper published – it’s about saving lives and getting the right products to market. RCA’s epidemiological consulting team will provide a custom scope of work based on your clinical research studies. For over 20 years we’ve partnered with clinicians, PhD’s, MD’s, and epidemiologists to increase the success of their initiatives, including clients from:

 

  • Hospitals and healthcare systems
  • Government agencies and departments
  • Academic and university research programs
  • Life science manufacturers and organizations
  • Private equity and venture capital

 

Regulatory Compliance Associates biostatistics consulting team provides a diverse set of healthcare consulting services during the clinical research trials process, including:

 

  • Biostatistics
    • Clinical trials
      • Phase 1 clinical trial
      • Phase 2 clinical trial
      • Phase 3 clinical trial
      • Phase 4 clinical trial
    • Medical trials
      • Clinical trial oversight
        • World wide clinical trials
        • Decentralized clinical trial
        • Randomized clinical trial
        • Clinical test oversight
        • Pragmatic trial
        • Open label studies

About Regulatory Compliance Associates

 

design protocolRegulatory Compliance Associates (RCA) provides biologics consulting & biotech 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.

 

 

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. 

 

Regulatory Compliance Associates® will be exhibiting at INTERPHEX in New York City from April 16th–18th 2024 with Sterigenics and Nelson Labs. Stop by booth #1753 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

 


About Interphex®

For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”.

Based in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.

 

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 and create a customized approach depending on your product and your pharma 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, 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 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, and we excel in transferring pharma consulting 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, 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. 

 

 

The US Food and Drug Administration (FDA) recently issued final guidance for Biologics industry executives to help define modifications to existing products and update submission procedures.  The primary focus of the guidance is to help biologics industry employees responsible for reporting understand which type of risk category is appropriate for updated variations in chemistry, manufacturing, and controls (CMC).

 

The guidance is applicable to CMC products with an existing biologics license application (BLA) currently approved by the FDA. It’s a critical update since any Biologics company or regulatory partners must notify the FDA about every change to an approved BLA under the Code of Federal Regulations (21 CFR 601.12).


Need help adhering to the New Guidance? Contact Us Now →


FDA submission data

 

FDA Guidance

The final FDA guidance goes into detail about each post-approval change in the product, including production process, quality controls, equipment and facilities, responsible employees, and established labeling. Expanded submission data will potentially provide greater detail about the the risk profile related to the changes, and how revised changes impact the intended safety or efficacy of the product.

 

Assessing and implementing manufacturing changes is laid out in great detail in the FDA guidance. Comparability data will be used to show variations of the product pre- and post- changes. The comparability analysis is necessary to help gauge possible effects of the product changes. Data from the analysis will be represented through a variety of sources, including a combination of testing, validation studies, and non-clinical or clinical studies.

 

FDA submission procedure

 

More importantly, the guidance provides a greater amount of detail about the updated FDA submission procedure. A significant focus of the guidance acknowledges the opportunity for adverse effects and how to measure and minimize based on data about the revised formulation. The biologic submission must show reference information that considers the new identity, strength of the product, quality of the product, and purity or potency of the product.

 

The three unique types of Biologics reporting includes Prior Approval Supplement, Changes Being Effected in 30 Days/Changes Being Effected (CBE30/CBE) and an Annual Report:

 

Prior Approval Support (PAS)

  • This includes changes that have significant potential for an adverse effect on product quality. The PAS must be approved by the FDA before a Biologics company can distribute any updated BLA approved product to the market involving the changes.

 

Guidance Changes Being Effected in 30 Days/Changes Being Effected (CBE30/CBE)

  • This includes changes that have a moderate potential to have an adverse effect on product quality. The CBE30/CBE requires an applicant to report the change to the FDA in a supplement at least 30 days before distribution of the product to the market.

 

Annual Report (AR)

  • This includes changes that have a minimal potential to have an adverse effect on product quality.

 

FDA process validation

 

Assessing the impact of the change on product quality is critically important in the reporting submission.  Reporting data should include prior knowledge and findings from product development activity. Documentation surrounding process validation activities and manufacturing expertise of the approved BLA product are also requested.

 

Quality risk management activities or pre-commercial studies that provide expanded awareness of the effects of the changes can also be very valuable for FDA decision makers. Finally, a cumulative impact assessment of multiple changes on the updated BLA product can help ensure post-market surveillance activities are aligned between the FDA and Biologics company.

 

Quality Management System

 

References to a robust quality culture appear throughout the guidance, including developing of robust manufacturing processes and process controls. Innovative process validation techniques and analytical testing are listed as critical drivers Biologics companies should practice to help mitigate risks associated with manufacturing changes.

 

Having an effective quality risk management system allows Biologics industry executives to make knowledgeable choices regarding manufacturing variations. The quality system data increases the confidence of product quality and process consistency for both executives and the FDA. Formal and informal risk assessments to support of post-approval manufacturing changes increases the accuracy of a more effective assessment of the change, which can increase the speed of the FDA’s decision.

 

About RCA’s Biologics & Biotech Consulting Services

Regulatory Compliance Associates® can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics consultants & consulting services include:

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®  backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

 

  • Preclinical & CMC Consulting
    • FDA Meetings & Briefing Package Assistance
    • Clinical Trial Applications
    • Marketing Applications
    • Medical Writing
  • Lifecycle Management
  • Submission Planning & Strategic Support
    • eCTD Publishing & Submissions
  • Strategic Consulting & Intelligence
  • US Agent
  • Project Management Support
  • Clinical Development Support
    • Clinical Research Organization (CRO) Sourcing
  • Analytical Development Support
    • Bioassay Design & Validation
    • Immunoassay Support
    • Statistical Analysis & Specification Setting

 

Compliance Assurance

 

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

 

  • Assessments
    • Current Good Manufacturing Practice (cGMP)
    • Corrective & Preventive Action (CAPA), Investigations & Deviations
    • Facility & Maintenance 
    • Data Integrity
    • Quality System Gap Assessment
  • Audits
    • Supplier Audits
    • CRO Audits
    • cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
    • cGLP Audits
    • Good Clinical Practices
  • Preparation, Training & Inspection Readiness
    • cGMP Fundamentals (Annual Training Required by Regulations)
    • Quality System Regulation
    • Risk Management
    • Investigations, Deviations & CAPA & Root Cause Analysis
    • Validation & Technology Transfer
    • Purchasing Controls & Supplier Management
    • Document Management & Change Control
    • Audit Readiness
    • Quality Culture & Management Responsibility
    • Data Integrity & 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

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics. Our biologics consultants goal is to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have 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.

 

  • Quality Management System Implementation
  • SOP Development
  • Document Control Systems
  • Change Control
  • Laboratory Operations & Control

 

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 complex remediation services challenges. With a proven track record of success, Regulatory Compliance Associates® biologics consultants have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
    • 483 Response & Remediation
    • Warning Letter Response & Remediation
    • Consent Decree Response & Remediation
    • Oversight Services
  • Consulting
    • Comprehensive Audits
    • Remediation Plan Development & Implementation
  • Manufacturing Support
    • Re-validation of Existing Equipment & Processes
    • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility 
    • Facility Improvements (Aging Facilities) 

 

Strategic Consulting

 

Whether it’s a corporate needs analysis, corporate growth / transformation strategy or due diligence / acquisition, Regulatory Compliance Associates®  worldwide biotech consulting experience can help ensure a successful mix of top-notch advice and people so your engagement is on time, on budget, and you’re never embroiled in a costly mistake.

 

  • Portfolio Management
  • Mergers & Acquisitions / Due Diligence
  • Staffing Support

 

About RCA

 

fda guidanceRegulatory Compliance Associates® (RCA) provides biologics consulting & biotech 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.

 

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 US Food and Drug Administration (FDA) has recently expanded on its clarification of a virtual audit, and how new manufacturing protocols in the COVID-19 environment will evolve. Travel constraints continue to impact the industry, especially in countries like India where a tremendous outbreak of COVID cases erupted in April 2021.

 

“This does show that indeed, we are very much interested in doing these remote interactive investigations, you know, especially the ones with video streaming technology.” said Michael Kopcha, director of the Office of Pharmaceutical Quality in the agency’s Center for Drug Evaluation and Research.


Looking for help preparing for the new guidance? Contact Us Now →


After reviewing recommendations from the European Medicines Agency (EMA) and the UK Medicines and Healthcare Regulatory products Agency (UK MHRA), the FDA continues to address the questions many pharmaceutical companies and partners have voiced during the pandemic. FDA officials commented that, due to these early learnings from other global regulatory bodies, they have recently expanded their recommendations for virtual audit best practices and new criteria of considering when to conduct a remote inspection.

 

Two of the initial primary use cases for virtual pharmaceutical inspections mentioned by the FDA include records requests and on-site inspectional work. While developing the new virtual audit process is still ongoing, one recommendation is Pharmaceutical companies should choose a proven regulatory partner to assist with the audit. Agency executives explained they will not be engaging vendors to perform virtual audits on behalf of the FDA.

virtual audit

 

One looming issue to be remedied is will virtual audits be allowed for facilities with serious good manufacturing practice (GMP) violations. FDA officials have expanded on their risk-based approach to prioritization in deciding which sites may qualify. An expanded virtual audit strategy continues to be a work-in-progress by agency officials including defining which companies qualify for an FDA virtual inspection and, more importantly, in what order the virtual audits may happen.

 

GMP violations involve either FDA warning letters or action-indicated site classifications based on the possible corrective actions needed. If the corrective actions needed for a facility can be successfully addressed remotely, it may become more likely that the number of hybrid virtual inspections authorized by the FDA will continue to grow. However, agency official commentary concluded that each facility will be examined by the FDA team on an individual basis with consideration of potential violations involved being a primary decision-making driver.

 

The good news for Pharmaceutical industry executives is it appears the FDA is willing to learn from international regulatory experiences and potentially even collaborate using technology in new ways to increase the FDA’s ability to continue operations. Global travel limitations will more than likely impact every industry for the foreseeable future in 2021 until the COVID-19 vaccine becomes more widely administered.

 

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 pharma consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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, 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 and regulatory compliance experience. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

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.

 

  • Compliance Enforcement
  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

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 pharmaceutical industry consultants are quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

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

 

Remediation Services 

 

Regulatory Compliance Associates has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. Our pharma consultants 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. 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 pharmaceutical industry consultant 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
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

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, 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.

 

 

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. 

 

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.

 

Cell and Gene Therapies also known as (ETMPs) have continued to evolve in recent years. Over the last 15 years the industry and regulatory bodies have continued to learn more about them and in recent year there have been more and more guidance documents released outlining what the regulating bodies want the manufacturers and developers of these different biologic products to look for and adhere to during development.

 

Cell and Gene Therapies are Personalized medicine meaning, one patient, one drug. These types of drugs are not produced in large scale or in batches like the standard biologics or drugs we have been used to manufacturing up to this point. They are made in very small batches that are produced in laboratory setting but require the same environmental controls as your typical aseptic processing but a much smaller scale.

 


Listen to the full episode “Pharmaceutical Industry Outlook” now!


 

Issues with Approval

The issues companies face when manufacturing cell and gene is that they are introducing variability right away in the process in terms of the active ingredient. In this type of manufacturing, the active ingredient is the specific patient’s genome. With the variable ingredient, manufacturers do not know what they are working with upfront which makes the process difficult. It is a non-tradition way of thinking that makes validating a process that has that kind of variability hard on cell and gene companies without experience in this area.

 

The Non-traditional Approach

This approach to drug approval is based on an individualized patient’s genetic makeup and requires the developers to make a constant process of taking the patient’s genetic material and producing the cell and gene therapy dose at the end. Developers have to be able to categorize the variable, walk it through the process, and then categorize it again at the end making sure it is safe and effective for the patient even though it is based on their cell and gene genetic material.

 

About RCA’s Biotech Consulting Services

 

Regulatory Compliance Associates® can assist you in ensuring the quality of your biologics or biosimilar product during its entire lifecycle. From pre-market to post-market reviews, inspection, and compliance, our Biotech consulting experts can shepherd your biologics through design, labeling, promotion, production, and testing. Our Biologics consultants & consulting services include:

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates®  backbone and we fully understand the complexities of the biologics industry. Our biotech consulting expertise spans all facets and levels of Regulatory Affairs, from early phase & bioanalytical sciences through late phase and post approval.

 

  • Preclinical & CMC Consulting
    • FDA Meetings & Briefing Package Assistance
    • Clinical Trial Applications
    • Marketing Applications
    • Medical Writing
  • Lifecycle Management
  • Regulatory Submission & Strategic Support
    • eCTD Publishing 
  • Strategic Consulting & Intelligence
  • US Agent
  • Project Management Support
  • Clinical Development Support
    • Clinical Research Organization (CRO) Sourcing
  • Analytical Development Support
    • Bioassay Design & Validation
    • Immunoassay Support
    • Statistical Analysis & Specification Setting

 

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 biologics consultants preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® biotech consulting global team can help.

 

  • Assessments
    • Current Good Manufacturing Practice (cGMP)
    • Corrective & Preventive Action (CAPA), Investigations & Deviations
    • Facility & Maintenance 
    • Data Integrity
    • Quality System Gap Assessment
  • Audits
    • Supplier Audits
    • CRO Audits
    • cGMP Compliance Audits: Manufacturing, Pilot Plant, Laboratory
    • cGLP Audits
    • Good Clinical Practices
  • Preparation, Training & Inspection Readiness
    • cGMP Fundamentals (Annual Training Required by Regulations)
    • Quality System Regulation
    • Risk Management
    • Investigations, Deviations & CAPA & Root Cause Analysis
    • Validation & Technology Transfer
    • Purchasing Controls & Supplier Management
    • Document Management & Change Control
    • Audit Readiness
    • Quality Culture & Management Responsibility
    • Data Integrity & 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

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics. Our biologics consultants goal is to ensure continuous improvement, aligning with your business needs and goals. Our biotech consulting subject matter experts have 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.

 

  • Quality Management System Implementation
  • SOP Development
  • Document Control Systems
  • Change Control
  • Laboratory Operations & Control

 

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 complex remediation services scenarios. With a proven track record of success, Regulatory Compliance Associates® biologics consultants have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
    • 483 Response & Remediation
    • Warning Letter Response & Remediation
    • Consent Decree Response & Remediation
    • Oversight Services
  • Consulting
    • Comprehensive Audits
    • Remediation Plan Development & Implementation
  • Manufacturing Support
    • Re-validation of Existing Equipment & Processes
    • Remediation of System Deficiencies Related to, Manufacturing Process, Equipment, or Facility 
    • Facility Improvements (Aging Facilities) 

 

Strategic Consulting

 

Whether it’s a corporate needs analysis, corporate growth / transformation strategy or due diligence / acquisition, Regulatory Compliance Associates®  worldwide biotech consulting experience can help ensure a successful mix of top-notch advice and people so your engagement is on time, on budget, and you’re never embroiled in a costly mistake.

 

  • Portfolio Management
  • Mergers & Acquisitions / Due Diligence
  • Staffing Support

 

Biostatistics

 

At Regulatory Compliance Associates, we recognize that biostatistics continues to change life science consulting one project at a time. Our biostatistics consultant Experts can help with both your internal or external clinical study and medical research needs.

 

RCA biostatisticians will create a custom scope of work based on the applicable statistical tests and predictive techniques that increase regulatory compliance. In fact, our statistical consulting team approach to clinical study design and clinical research provides Regulatory Compliance Associates clients a true competitive advantage during product development and commercialization. 

 

Our biostatistics consulting services include:

 

  • Clinical research
  • Medical research
  • Epidemiological research
  • Disease occurrence research
  • Disorder prevalence research
  • Data safety monitoring
  • Adverse event research

 

Regulatory Compliance Associates healthcare consulting Experts can provide quantitative analysis that propels your commercialization projects faster and more accurately. Our statistical consulting Experts can provide deep insights into the regulatory compliance process of what can help you with your regulatory submission.

 

Biostatistics is more than just getting your white paper published – it’s about saving lives and getting the right products to market. RCA’s epidemiological consulting team will provide a custom scope of work based on your clinical research studies. For over 20 years we’ve partnered with clinicians, PhD’s, MD’s, and epidemiologists to increase the success of their initiatives, including clients from:

 

  • Hospitals and health care systems
  • Government agencies and departments
  • Academic and university research programs
  • Life science manufacturers and organizations
  • Private equity and venture capital

 

Regulatory Compliance Associates biostatistics consulting team provides a diverse set of healthcare consulting services during the clinical research trials process, including:

 

  • Biostatistics
    • Clinical trials
      • Phase 1 clinical trial
      • Phase 2 clinical trial
      • Phase 3 clinical trial
      • Phase 4 clinical trial
    • Medical trials
      • Clinical trial oversight
        • World wide clinical trials
        • Decentralized clinical trial
        • Randomized clinical trial
        • Clinical test oversight
        • Pragmatic trial
        • Open label studies

About Regulatory Compliance Associates

 

Regulatory Compliance Associates (RCA) provides biologics consulting & biotech 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.

 

 

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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