Darshan Kulkarni, Esq.

Personal Introduction

Dr. Kulkarni advises clients on issues varying from FDA regulatory strategy, clinical trial negotiations, manufacturing audits, FDA compliant promotional and non-promotional review, FDA responses, to genericization and other interdependent processes. Prior to starting the Kulkarni Law Firm, Darshan was the Global Corporate Counsel for an international pharmaceutical holding company, where he provided services including writing licensing and employee contractor agreements, warning letters and SOPs. He was also responsible for developing a quality system for the facility and engaging with the FDA. In his spare time, Darshan regularly contributes to his pharmacy podcast DarshanTalks, and has written for multiple editions of several books on life sciences laws including the chapters on drug advertising, medical devices, pharmacy compounding and clinical research for the ABA's flagship textbook on pharmaceutical law titled, "Pharmaceutical Law and Medicine Law", the chapter on the Indian pharmaceutical industry in Principles and Practice of Pharmaceutical Medicine and a chapter on clinical research on Research Compliance Professional’s Handbook.