ABOUT
Darshan Kulkarni is the Principal Attorney at the Kulkarni Law Firm (kulkarnilawfirm.com) and focuses on helping with the regulatory, compliance, and due diligence needs of FDA-regulated companies and high-growth sectors, including drug and biopharmaceutical companies, pharmacies, clinical research sites, emerging medical spas (medspas), and digital health platforms navigating complex state compounding and corporate practice of medicine regulations. Dr. Kulkarni has a Doctorate in Pharmacy and a Juris Doctor degree.
Dr. Kulkarni is regularly called on to advise on legal, regulatory and compliance issues related to clinical research, promotional compliance, manufacturing, pharmacy, medical affairs and other FDA-related transactions. Accordingly, he is also often consulted during the purchase or sale of FDA-regulated companies to evaluate latent liabilities, such as sensitive gender-identity data privacy governance under GDPR/CCPA, or to perform rigorous M&A due diligence to mitigate multi-agency fraud enforcement within the medical aesthetics space.
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, among others.
Scholarly Work
Dr. Kulkarni has written chapters for several editions of multiple books including content on promotional compliance, medical devices, reimbursement, pharmacy, and clinical trials.
Dr. Kulkarni has been invited to give keynote speeches both across the US and internationally on various life science related topics.
He is currently an adjunct professor at Drexel University School of Law where he teaches on food and drug law and promotional compliance. Formerly, he was Visiting Professor at the former University of the Sciences in Philadelphia (now St. Joseph’s University), and presented at grand rounds for Vanderbilt University and Children’s Hospital of Colorado. He has held multiple educational positions, including lecturing at University of Florida, University of Southern California, and Villanova University.
His recent thought leadership focuses on the intersection of healthcare compliance and corporate transaction risk, including the erosion of the “unregulated medspa” myth amid federal peptide crackdowns, and the millions of dollars in business and litigation exposure life sciences companies face when mishandling sensitive gender identity information.
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.
You can reach Dr. Kulkarni at [email protected] or @kulkarnilawfirm (https://x.com/kulkarnilawfirm) on X or via Linkedin at https://www.linkedin.com/in/darshankulkarni/.
