Rochelle, Virginia (October 21, 2015) - Dr. Carl Peck, MD, Chairman of NDA Partners LLC announced today that Roger L. Williams, MD, has joined the firm as a Premier Expert consultant. NDA Partners Premier Experts are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company’s clients. Premier Experts collaborate to design and implement critical solutions to help clients successfully develop their medical products, pursue optimal regulatory pathways, build companies that are attractive to professional investors, and initiate access to global markets.
Dr. Williams is an expert in clinical pharmacology and Board certified in clinical pharmacology and internal medicine. He was most recently Chief Executive Officer and Chair of the Council of Experts at the US Pharmacopeial Convention (USP). Prior to that he served in various positions at the FDA Center for Drug Evaluation and Research (CDER), including Director of the Office of Generic Drugs; Deputy Center Director, Office of Pharmaceutical Sciences; and Acting Director for New Drug Chemistry. He took on leadership roles nationally and internationally for FDA at the World Health Organization, the Pan American Health Organization, and, as FDA lead, the International Conference on Harmonization. In these capacities, Dr. Williams contributed to many important initiatives, including a WHO guidance, which supported interchangeable multisource medicines, and many guidances on the topics of safety, efficacy, quality, and regulatory communications at ICH.
“Dr. Williams’ expertise in pharmacology will be invaluable to our clients in every stage of drug development. He is also a proven leader, nationally and internationally, making him a welcome addition to the NDAP team.” said Dr. Peck.
Dr. Williams is a fellow of the American Association of Pharmaceutical Scientists and a former expert member of the International Pharmacy Federation Board of Pharmaceutical Sciences. He has received a Doctor of Science degree, honoris causa, from Long Island University and has authored or co-authored more than 200 publications on topics related to applied regulatory and compendial science as well as national and international health.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 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, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, General Manager