Ajit Simh
Head - Corporate Quality / Regulatory Compliance
biotechnology / pharmaceutical
Syngene International (Biocon)
India
Biography
Ajit has over 30 years of experience in the biotechnology / pharmaceutical industry in the R&D, production, operations and regulatory compliance domains. Over the years, he has gained an excellent understanding on the global regulatory compliance requirements by the US FDA and ICH bodies for the manufacture and control of small and large molecule API’s and oral and parenteral dosage forms.
Research Interest
He has worked with several global companies including Mallinckrodt, Inc., Abbott Biotech and Baxter Healthcare. He is an adjunct professor with a dual appointment at the University of California, San Diego and San Diego State University teaching classes in the M.S program in regulatory compliance and advanced quality. Ajit is associated with Syngene since 2014.
