At Regulatory Compliance Associates^®, our consulting team of experts can assists Law firms in helping their clients with legal challenges. 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.

Regulatory Compliance Associates^® 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. Lynn, Executive Principal Consultant for Regulatory Compliance Associates^® 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 Regulatory Compliance Associates^®, 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.

Regulatory Compliance Associates^® can help your client who 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).

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.