The U.S. Food and Drug Administration regulates pharmaceutical, medical device, food, cosmetic and dietary supplement manufacturers and suppliers. Legal advocacy for regulated industries requires an understanding of both the industry itself and these regulatory schemes. At Hutchison, we offer premier FDA regulatory advice, as well as seamless integration with our corporate life sciences practice. This enables clients faced with corporate, transactional, regulatory and compliance matters to call on one team, without any disruption. We regularly counsel pharmaceutical and biotech clients throughout the product development life cycle. Our firm is able to assist with the legal and regulatory aspects of clinical trial and CRO agreements, compassionate use and expanded access programs, supply chain, licensing and strategic transactions, marketing and promotions and effective compliance programs. Likewise, we provide counsel to medical device, cosmetic, food and dietary supplement companies regarding all aspects of their businesses, with a particular emphasis on balancing risks and costs/efficiencies. Our experienced attorneys bring a creative, entrepreneurial mindset when providing advice, as well as the technical expertise required for effective legal counseling.
Our firm also assists pharmaceutical, medical device and other life sciences companies with mergers and acquisitions, collaborations, joint ventures, alliances, university licensing, financings and securities compliance. Specifically, for FDA-regulated companies, we bring integrated legal advice that combines sophisticated corporate representation with a deep knowledge and understanding of the relevant regulatory and compliance environments in which our clients thrive.