Introduction:

Darshan Kulkarni is the Principal Attorney at the Kulkarni Law Firm (kulkarnilawfirm.com ) and focuses on helping with the regulatory and compliance needs of FDA-regulated companies and their service providers including drug, device, and biopharmaceutical companies, advertising agencies, and even other law firms. Dr. Kulkarni has, amongst other degrees and certificates, a Doctorate in Pharmacy, a Masters in Quality Assurance/ Regulatory Affairs, and a Juris Doctor degree. Dr. Kulkarni is regularly called on to advise on compliance issues related to promotional and non-promotional communications including in the context of medical affairs, advertising, health economics, and more. He is also often consulted during the purchase or sale of FDA-regulated companies.

Hobbies:

Dr. Kulkarni is a prolific content creator, including currently as host of the DarshanTalks podcast where he interviews high-profile life science stakeholders including governmental officials, the C-Suite, bioethicists and more. Dr. Kulkarni serves on multiple advisory and editorial boards, sharing his knowledge on professional, community and professional issues. Current boards include the Emily Whitehead Foundation and the Father Center of New Jersey, among others.

Scholarly Work:

Dr. Kulkarni has written chapters for several editions of multiple books, spoken all over the world, and been quoted in various articles on promotional compliance issues. Dr. Kulkarni has been invited to give keynote speeches both across the US and internationally on various life science related topics. He has held multiple educational positions, including lecturing at University of Florida, University of Southern California, Villanova University, being Visiting Professor at the former University of the Sciences in Philadelphia (now St. Joseph’s University), presenting at grand rounds for Vanderbilt University and Children’s Hospital of Colorado. He is currently an adjunct professor at Drexel University School of Law where he teaches on food and drug law and promotional compliance. 

Innovation:

Dr. Kulkarni holds multiple copyrights and trademarks for software products and services aimed at solving life science challenges including Ceres (goceres.com), which allows for compliant sharing of information, and Minos, which provides compliance review services.