Our Life Sciences Industry Team provides a full range of legal and consulting services related to life sciences product innovation to pharmaceutical, medical device, and biotech companies, as well as research institutions, scientists, venture capitalists, and investment banks.
Our lawyers, many of whom have additional experience in a variety of scientific disciplines, are joined by Ph.D. chemists and policy analysts to form fully integrated teams that provide the appropriate expertise for a client's specific requirements. We advise a variety of life sciences companies - from small and midsized corporations focused on product development and research to major multinational pharmaceutical and medical device companies - on the scientific, regulatory, and national and global business issues and perspectives.
We are experienced in the formation of focused industry consortia that address common scientific, regulatory and policy goals of clients. Given the highly regulated nature of U.S., European and international life sciences and pharmaceutical markets, companies often are well served by responding jointly to governmental proposals or emergent regulatory regimes that affect core interests of that industry. Through the development of industry consortia, we facilitate a functional consensus-building process and assist companies in efficiently devising and executing their common initiatives in the United States, the European Union and around the world. We have formed and represent trade associations that are devoted to a wide variety of life sciences issues, including orally inhaled and nasal drug products for local and systemic treatment of a variety of diseases; protection of personal health information; clinical research; and metered dose inhalers containing chlorofluorocarbons and hydrofluorocarbons.
We frequently counsel clients on life sciences policy issues. We represent companies and associations in rulemaking proceedings before organizations such as the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), and we continuously monitor and attempt to influence domestic and international legislation.
We provide specialized expertise in a number of areas, including filing formal comments with the FDA and EMEA relating to bioequivalence and bioavailability; toxicological and quality-assurance testing programs; and preparing and filing Drug Master Files.
To read the Life Sciences team's blog, Life Sciences Now, visit www.lifesciencesnow.com.