K&L Gates' FDA practice, focusing on food, drug, device, and cosmetic regulatory and compliance matters, is an experienced and integrated team with a proven track record in all areas the FDA regulates. We help clients navigate the regulatory process throughout the life cycle of their products—from planning and development, to approval and marketing, to enforcement and ongoing compliance.
In addition to addressing regulatory issues after companies have funding and patents in hand, we assist with regulatory due diligence and other transactional needs. Our clients include domestic and international manufacturers and distributors of food, dietary supplement, pharmaceutical, biological, medical device, tobacco, personal care, and cosmetic products, as well as trade associations, individuals, and institutions involved in preclinical and clinical research of FDA-regulated products.
We offer clients multidisciplinary, global, regulatory, and transactional advice to help address FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), Consumer Product Safety Commission (CPSC), and other agency hurdles. We have excellent working relationships across the government agencies that regulate life science companies.
We Understand the Science
Our FDA team not only has significant legal and regulatory experience, but many of us have scientific degrees in areas such as biology, molecular biology, neuroscience, and engineering, as well as first-hand experience with biomedical research. As the scientific landscape continues to evolve, we have the knowledge necessary to assist clients with the regulatory challenges affecting new drugs, monograph drugs, alternative medicines and therapies, medical devices, radiological products, food, nutraceuticals, dietary supplements, medical food, cosmetics and other personal care and “combination” products.
Our Global Platform
K&L Gates’ global platform allows our FDA team to offer domestic, international, and multinational companies 24/7 availability and a unique position from which to advise on research, approval, registration, import, export, and recall matters involving FDA-related issues on the East and West coasts of the United States, as well as throughout Canada, the European Union (EU), Japan and the Pacific Rim, Latin America, and other markets.