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Shruti R. Kulkarni, Esq.

Shruti R. Kulkarni, Esq.

Associate Attorney

Licensed to practice in Maryland

Ms. Kulkarni provides legal, regulatory, and policy counsel to pharmaceutical and biotechnology companies. She provides guidance throughout the product lifecycle, including medication development, labeling, distribution, dispensing, and disposal.

In the area of medication development and approval, Ms. Kulkarni has assisted clients with market assessment, expedited review procedures, advisory committee meetings, and risk mitigation strategies. Post product approval, she has advised clients on matters of compliance, advertising and promotion, and reimbursement.

Ms. Kulkarni also offers unique policy insight on issues of diversion, misuse, and abuse of controlled prescription medications and illicit substances, and prevention and treatment of substance use. In this capacity, she has analyzed existing and proposed policies and legislation; drafted legislative language, testimony, and white papers; and educated state and federal legislators and policy makers. Ms. Kulkarni is also the policy director for the Center for Lawful Access and Abuse Deterrence (CLAAD).

Ms. Kulkarni has more than 10 years of experience in the health care industry, including working for pharmaceutical companies in sales and government affairs positions. Immediately prior to joining the firm, she completed a legal internship at the U.S. Food and Drug Administration’s Office of Policy in the Office of the Commissioner where she provided input on First Amendment-related matters; and worked on Food Safety Modernization Act’s Proposed Rule for Produce Safety.

Ms. Kulkarni obtained her Juris Doctor degree from George Mason University School of Law, where she served as a Writing Fellow, teaching first year law students legal research, writing, and analysis. She also served on the school’s Moot Court Board and represented the school on the Moot Court Board’s National Team. She received her bachelor’s degree magna cum laude from Saint Joseph’s University.