The Institute of Pharmacy, Nirma University, successfully hosted an Expert Lecture on 13th June 2025, featuring Dr. Darshan Doshi, Deputy General Manager, Regulatory Affairs, Zydus Lifesciences Limited, Ahmedabad, for M.Pharm. semester II students of Regulatory Affairs. Dr Darshan delivered an expert talk on “Managing the Lifecycle of Regulated Products in the USA- With Case Studies”.
With more than a decade of experience as an expert in the field of Regulatory Affairs, Dr. Doshi provided invaluable insights into various regulatory aspects throughout the world, with a specific focus on the USA. He provided details to the students regarding Activity flow – Pre-ANDA submission, List of documents for ANDA, GDUFA Fees, Activity flow – Post ANDA Submission and Common Post Approval Changes observed in the industries. He then discussed various case studies on Post approval Changes and gave insight to students regarding the interpretation of queries raised by regulatory bodies and action taken by the industries.
The session concluded with an engaging Q&A discussion, where students asked questions with curiosity and explored career opportunities in the field of Regulatory Affairs.
