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

Eric B. Sheinin, PhD

Practice Area Focus

  • Combination Products
  • Drugs
  • Generics
  • CMC
  • Compendial

Biography

Dr. Eric Sheinin joined NDA Partners as an Expert Consultant in 2017. He is an expert in CMC review and issues relating to the drug approval and regulatory processes both in the US and internationally. Dr. Sheinin served in several executive roles at the US Food & Drug Administration (FDA) in the Center for Drug Evaluation and Research (CDER) over his 30-year career including, Deputy Director, Office of Pharmaceutical Science; Director, Office of New Drug Chemistry, Office of Pharmaceutical Science; and Director, Division of New Drug Chemistry III, Office of New Drug Chemistry. In addition to his FDA experience, he served as Vice President, Pharmaceutical Ingredient Verification Program, and Vice President and Chief Scientific Officer at the United States Pharmacopeia (USP).

Dr. Sheinin is a charter member of the American Association of Pharmaceutical Scientists and member of the USP Nomenclature and Labeling Expert Committee. He has authored/co-authored 40 scientific publications and over 200 presentations.