Healthcare & Life Sciences Regulatory

Our regulatory team of 130 lawyers advises the world’s leading life sciences companies on their regulatory strategies, assisting our clients as they navigate complex government regulations throughout the product life cycle, providing sophisticated advice on regulatory issues for drugs, biological products, medical devices, human cell and tissue products, veterinary products, foods and dietary supplements. From start-ups to multinational corporations, clients call on us to shepherd their products through to market, assist in maintaining compliance with evolving local regulatory requirements, and manage regulatory enforcement actions.

Our team includes lawyers with previous in-house experience working for life sciences companies, as well as lawyers that hold higher degrees in chemistry, molecular biology, biotechnology, biochemistry, microbiology, pharmacology, and bioethics. Members of our team previously worked for the FDA and EMA, and we have a handful of lawyers who worked with other healthcare regulators in Europe, Latin America and Asia Pacific. We have close relations with industry trade associations, with many of our team members holding leadership positions with these organizations, and are able to respond quickly and consistently monitor regulatory developments. This knowledge ensures a deep understanding of issues related to regulatory compliance, commercialization of products, marketing and promotion and supply chain arrangements.

We regularly work to resolve regulatory issues in relation to clinical investigations, maintaining national level registrations, labeling and product information variations, reimbursement applications, product surveillance and adverse event reporting, advertising and promotion, classifications and CE marking on behalf of clients.

We are also often asked to coordinate and provide advice on global regulatory surveys, sometimes for more than 50 countries, covering issues pertaining to local healthcare regulations such as classification of products, telemedicine regulations, biosimilar regulations, orphan drugs regulations, clinical development, market access, data privacy laws, transparency laws, and rules governing interactions with healthcare professionals.