At Regulatory Compliance Associates® Inc, our Regulatory Legal Services team of experts can assists Law firms in helping their clients with. Our solutions include quality protocols, operation efficiency, getting products to market, federal acquisition regulation by executing due diligence, as well as GMP and GCP remediation enforcement responses.

 

RCA® Inc. has been an Expert Witness for clients providing product regulation compliance and quality for pharmaceutical and medical device operations. As an Expert witness, we can ensure that you and your clients have the right expert for each case.

 

Meet Your Expert Witness

 

Steven J. LynnSteven J. Lynn, EVP of Pharmaceuticals for RCA® Inc. has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries.

 

Prior to joining RCA, Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US Food and Drug Administration (FDA). His professional experience includes:

 

  • Food & Drug Administration
    • Center for Drug Evaluation and Research (CDER)
      • Director of Office of Manufacturing and Product Quality (OMPQ)
      • Office of Pharmaceutical Quality (OPQ)
        • Operations Transition Lead 
    • Office of Regulatory Affairs
      • Director for Office of Medical Products and Tobacco Operations (OMPTO)
      • Office of Operations
        • Senior Advisor to the Assistant Commissioner for Operations (ACO)
  • Novartis AG
    • Global Head of Group (Corporate) Compliance and Audit
  • Mylan, Inc.
    • Vice President of Global Quality Compliance

Click now to read Steve Lynn‘s executive bio.

 

RCA® Inc. can help your client that either has to remediate a problem that they’ve self-identified or a problem that a Health Authority (ex: FDA) has identified in an inspection. We have the ability to get you the help you need within the tight response window each regulatory body provides.

 

We can also provide assistance with transitioning to new or updated regulations such as the European Medical Device Regulations (EU MDR), In-vitro Diagnostic Regulations (IVDR), and the European territorial cooperation (ETC).

 

 

Since 2000, thousands of companies across the world have trusted RCA® Inc. to care for their unique regulatory compliance needs. Our Regulatory Legal Services expertise is backed by more than 500 professionals, including FDA veterans and other subject experts who are here to guide you through every step of the regulatory compliance process. Whether you’re a Fortune 100 company or a small enterprise, trust RCA® Inc. to partner with you to tailor an ideal compliance services solution.

 

About RCA® Inc.

 

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

 

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

 

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

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