When private equity firms pursue life sciences industry targets, Amy Dow provides a clear picture of the potential regulatory and compliance impacts of their investments. Investors appreciate Amy’s measured approach to addressing risk and her ability to explain challenges in a commercial context. She quickly assembles multidisciplinary teams of lawyers and technical advisors to provide a complete view of a target company’s regulatory risk profile, including existing investigations and enforcement, FDA inspection history, quality and compliance obligations, data privacy and security practices, and litigation risk. Whether she’s advising on a current regulatory enforcement action or recommending post-acquisition compliance program enhancements, Amy tailors solutions to her clients’ risk tolerance and investment objectives.
Pharmaceutical, biotechnology, and medical device companies regularly call on Amy’s counsel to support development and commercialization of their products. Her practical advice helps development-stage companies intensify their compliance efforts as they expand their operations, develop promotional strategies, and launch sales teams. Amy frequently helps non-U.S. companies entering the U.S. market to prepare for heightened compliance expectations, tough regulatory scrutiny of their drug and medical device products and the U.S. reimbursement environment. For established companies, she leads teams of lawyers and former in-house compliance officers who assess their existing compliance programs, spot weaknesses, and implement strategies to mitigate future risks. Sponsors, contract research organizations, and clinical research services providers also rely on her advice when structuring relationships for product development and clinical research services.
Amy is Vice Chair of Epstein Becker Green’s National Health Care & Life Sciences Steering Committee. She received an undergraduate degree in microbiology. Before she became a lawyer, Amy worked for five years as a senior clinical research associate at a large contract research organization, where she monitored pharmaceutical clinical trials and led regulatory compliance training programs.