NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Vinod Shah, PhD, Former Senior Research Scientist in FDA Office of Pharmaceutical Sciences, Joins NDA Partners as Expert Consultant

Rochelle, Virginia (April 3, 2017) – NDA Partners Chairman Carl Peck, MD, announced today that Vinod Shah, PhD, former Senior Research Scientist in the Office of Pharmaceutical Sciences (FDA) and Biopharmaceutics Expert Committee member of U.S. Pharmacopeial Convention (USP) has joined the company as an Expert Consultant.

Dr. Vinod Shah has thirty years of experience and leadership in the FDA, working in several Divisions, until he retired as a Senior Research Scientist in the Office of Pharmaceutical Sciences in 2005. During his career at FDA, he led the development numerous regulatory guidances for Industry in areas such as dissolution, SUPAC, bioanalysis, bioequivalence, biopharmaceutics, and topical drugs. Dr. Shah has also worked at Sarabhai Chemicals, Baroda, India. He served as Scientific Secretary of the International Pharmaceutical Federation (FIP), as Adjunct faculty at JSS University, India, and Adjunct Professor at College of Pharmacy, University of Kentucky. Dr. Shah has authored more than 260 scientific papers and three books. His honors include the AAPS Presidency and the AAPS Distinguished Service Award, and the Pharmaceutical Sciences World Congress (PSWC) Research Achievement Award. He is a recipient of International Pharmaceutical Federation (FIP) Lifetime Achievement Award in Pharmaceutical Sciences and holds an Honorary Doctorate from Semmelweis University.

“Dr. Vinod Shah’s extraordinary experience of the pharmaceutical sciences, including bioanalysis, bioequivalence, and biopharmaceutics, will provide an outstanding resource to our clients and our growing CMC and Non-clinical Regulatory Practices,” said Dr. David Savello, Head of the CMC Practice. “We are pleased to welcome him to NDA Partners.”

Dr. Shah is a former Biopharmaceutics Expert Committee member of USP. He was Co-Chair of USP’s Advisory Panel on Dosage Form Performance – Topical/Dermal, and Distinguished Pharmaceutical Scientist/Consultant at USP in Biopharmaceutics. He is a member of the Steering Committee of Non-Biological Complex Drugs (hosted at Lygature, The Netherlands), and Founder and Chairman of the Society of Pharmaceutical Dissolution Science (SPDS) International. In addition, Dr. Shah was a Board Member of the Product Quality Research Institute (PQRI) from 2013-2017.

Dr. Vinod Shah earned his PhD in Pharmaceutical Chemistry from the University of California, San Francisco and a Gold Medal degree in Pharmacy from Madras University, India. Dr. Shah is the recipient of many professional awards, including AAPS Distinguished Service Award; Pharmaceutical Sciences World Congress (PSWC) Research Achievement Award; FIP Lifetime Achievement Award in Pharmaceutical Sciences; and two Honorary Doctorates from Semmelweis University, Hungary and the University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania.

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 three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; 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, expert consulting, high-impact project teams, and virtual product development teams.

Earle Martin, Chief Executive Officer
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