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Experts

Natasha Leskovsek

Specialties: FDA regulatory counsel, including:

  • Strategy for drug and biopharmaceutical approval
  • Device and diagnostics pathways: 510(k), PMA, LDTs
  • When and how to seek advice from FDA
  • Compliance issues for clinical research and development

Natasha Leskovsek is a partner in the Business Department. She joined the firm in 2008 and is resident in the Washington, DC office. Ms. Leskovsek advises pharmaceutical, biotechnology, medical device and food/dietary supplement industry clients on FDA regulatory and clinical development matters. She also conducts regulatory diligence on behalf of entities investing in FDA-regulated companies. Before joining Cooley, Ms. Leskovsek was a shareholder at Heller Ehrman. Prior to entering the law, Ms. Leskovsek worked as a registered nurse in pediatric oncology research at the National Institutes of Health (NIH) and with adult medical and surgical patients. Ms. Leskovsek worked as a consultant for international pharmaceutical and biotech clients while attending Georgetown University Law Center. Her direct clinical trial experience in nursing and project management offers her a unique perspective in advising clients on the conduct of clinical trials in product development and postmarketing studies. She has authored numerous healthcare and FDA-related publications and regularly speaks on a broad range of FDA regulatory topics for national conferences and meetings. Ms. Leskovsek received her J.D. from Georgetown University Law Center in 1996 and her M.B.A and M.P.M in 1991 from the University of Maryland, College Park. She received her B.S.N. from University of Maryland, Baltimore in 1989. Ms. Leskovsek is admitted to practice in the District of Columbia and Maryland and is a member of the editorial advisory board of the Food and Drug Law Institute and a member of the American Health Lawyers Association.