Sonia has deep experience in matters involving the Food and Drug Administration (FDA). Her practice encompasses regulatory counseling, investigations and litigation, as well as advising on transactional matters. She routinely counsels clients on FDA regulatory compliance including reviews of labeling, advertising and promotion; developing go-to-market strategies for companies, particularly in the medical device space; and working hand-in-hand with business leaders to ensure the regulatory pathways align with the overall business strategy, including plans for developing and protecting intellectual property. Sonia has experience working across all FDA-regulated product areas, with a particular emphasis on the biotech and medtech industries.
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