We understand the challenges and opportunities that arise in a highly complex regulatory scheme and ensure that our clients are in compliance with FDA regulations across the entire product lifecycle, from research and development through clinical trials, FDA review and post-marketing. We work collaboratively with our clients to craft effective regulatory strategies for novel therapies and technologies, including combination products, cell and gene therapies, and biotechnology products.

Our deep understanding of the FDA Regulatory and Enforcement landscape allows us to guide companies through FDA interactions while avoiding many of the common pitfalls that can delay or derail product development. When obstacles do arise, we develop and implement effective strategies to overcome them, including meetings with agency stakeholders, informal and formal dispute resolution, and where necessary, administrative and litigation challenges to the agency. We also provide advice to companies and executives in government investigations, litigation, and related regulatory and enforcement inquiries implicating health, safety, and fraud laws.

We routinely work with M&A, Capital Markets, Emerging Companies & Venture Capital, and IP colleagues to advise Life Sciences clients on complex transactional matters, including mergers and acquisitions, licensing agreements, and a variety of funding transactions.