Select Page

Former Team Leader, USFDA and Vice President and Head of Regulatory Practice, Lachman Consultants

  • Dr. Srinivasan worked in FDA prior to joining industry as a team leader at Office of Generic Drugs and spearheaded the establishment of the DMF review division in CDER based on GDUFA.
  • Dr. Srinivasan is also the representative of International Generics and Biosimilar Medicines Association (IGBA) in ICH Q11 Q&A Implementation Working Group (IWG).
  • Prior to joining Lachman, Dr. Srinivasan was the Vice President of Regulatory, Lupin Pharmaceutical Inc.
  • Prior to joining FDA, Dr. Srinivasan was a senior scientist at National Cancer Institute (NCI).
  • Dr. Srinivasan did her Ph.D. at University of Missouri, Columbia under late Dr. Richard Loeppky of nitrosamine fame. Her thesis involved studying of intermediates in activation of beta-hydroxy nitrosamines.