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Former FDA CDRH Director, Office of Compliance, Joins NDA Partners as Expert Consultant

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Mr. Silverman’s experience serving in leadership roles at FDA and in the medical product industry will be valuable to clients and law firms in matters related to regulatory, policy, and compliance issues.


WASHINGTON (PRWEB)

NDA Partners General Manager, Eric Fish, announced today that Steve Silverman, former Office of Compliance Director in FDA’s CDRH, has joined the company as an Expert Consultant. Mr. Silverman’s professional experience includes two decades in federal service including Director-level positions in FDA’s Offices of Compliance in CDRH and the Center for Drug Evaluation and Research (CDER). There, he led quality and compliance initiatives, regulatory implementation, policy development, and public communications about medical devices and drugs. Mr. Silverman began his FDA service as an Associate Chief Counsel, where he handled legal actions against medical device and pharmaceutical companies. His professional experience also includes positions with the US Department of Justice, Federal Trade Commission, and AdvaMed, a medical device trade association.

Mr. Silverman serves as a consultant to medical product companies, providing guidance on matters including regulatory strategy, product quality and compliance, pre-market oversight, and stakeholder communications. According to Deb Koeneman, Manager of NDA Partners’ medical device development practice, “Mr. Silverman’s experience in leadership roles at FDA and in the medical product industry will be valuable to clients and law firms requesting experts to support legal matters related to regulatory, product quality, policy, and compliance issues.”

Mr. Silverman earned his JD from The University of Pennsylvania School of Law and bachelor’s degree from The University of Michigan. He is a member of the State of Illinois and Washington, DC Bar Associations.

About NDA Partners

NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.

Contact

Eric Fish, General Manager

Office: 540-738-2550

FishEric@ndapartners.com

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