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

Vinod P. Shah, PhD

Practice Area Focus

  • Generics
  • CMC

Biography

Dr. Vinod P. Shah joined NDA Partners as an Expert Consultant in 2016. He has thirty years of experience at the FDA, working in different Divisions, until he retired as a Senior Research Scientist in the Office of Pharmaceutical Sciences in 2005. During his career at FDA, he developed several regulatory guidances for Industry in areas such as dissolution, SUPAC, bioanalysis, bioequivalence, biopharmaceutics, and topical drugs. In addition to his career at FDA, Dr. Shah 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 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 is a Board Member of the Product Quality Research Institute (PQRI).