Darshan Kulkarni,

Areas of Experience

Life Sciences/Pharmaceutical Regulatory Law, Pharmaceutical and Biopharmaceutical Transactions, licensing, contract negotiations, Clinical Trials, Quality Assurance, FDA Relations, Product Lifecycle Management

Experience and Background

Dr. Kulkarni is the Principal Attorney at Kulkarni, LLC. He focuses on strategic regulatory and pharmaceutical counseling and has extensive experience handling the needs of international pharmaceutical, biopharmaceutical and medical device companies and their service providers including Contract Manufacturing Organizations, Contract Research Organizations.

As Corporate Counsel for a reputable, international Pharmaceutical holding company, Dr. Kulkarni provided corporate and regulatory legal advice to international pharmaceutical, biopharmaceutical and medical device companies. He has had experience in Corporate Quality Control and has worked in crafting responses to FDA 483s, and negotiating with and for CROs and SMOs.

Additionally, Dr. Kulkarni has worked as a pharmacist in multiple capacities, including hospitals, retail pharmacies, managed care and and has even participated as a clinician in clinical trials.

Besides helping pharmaceutical and biopharmaceutical companies, Dr. Kulkarni also serves as Adjust Professor  at the prestigious University of the Sciences in Philadelphia (USP) (Formerly, the Philadelphia College of Pharmacy and Sciences' Biomedical Writing Program and has taught courses in both Regulatory Documents and Law and Ethics for Biomedical Writers. The University is responsible for the United States Pharmacopoeia (USP) and for publishing the world famous Remingtons: The Science and Practice of Pharmacy.

Dr. Kulkarni has also authored a chapter, on the Indian Pharmaceutical Industry , in the soon to be published 3rd edition of the textbook entitled Principles and Practice of Pharmaceutical Medicine. He has also recently been published in the preeminent, Indian, pharmaceutical trade journal "Express Pharma" for his article on Clinical Trial Negotiations.

Dr. Kulkarni formerly served as a law clerk for the Hon. Clifford Scott Green in the Eastern District of Pennsylvania.