Svetlana Lyapustina, Ph.D. counsels individual companies and consortia comprised of industry, government and academia representatives on a wide range of topics related to medical product development (pharmaceuticals, medical devices, biologics, and combination products), quality control, manufacturing, regulatory compliance, patient adherence, and regulatory submissions.
Svetlana has represented clients in interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, the Medicines and Healthcare Products Regulatory Agency (MHRA), the U.S., Japanese and European Pharmacopoeias (USP, JP and EP), the International Organization for Standardization (ISO) and other regulatory, governmental and scientific agencies in the United States and other world regions. Her specialty is helping people address complex regulatory and technical problems constructively.
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