regulatory strategy and policy consultant
Darshan Kulkarni is the principal attorney at the Kulkarni Law Firm and focuses his practice on helping U.S. Food and Drug Administration (FDA)-regulated companies successfully promote their products. He has spent more than 20 years advising clients on regulatory compliance issues and has served as a pharmacist for over a decade.
Kulkarni has experience serving on legal regulatory boards in addition to helping companies navigate a variety of compliance matters arising under the Federal Food, Drug and Cosmetic Act that relate to product labeling and advertising, FDA submissions and responses to FDA enforcement activities.
He has also written several book chapters on regulatory compliance for various publications on behalf of the American Bar Association where he serves as chair of the Life Sciences Interest Group.