Pharmaceuticals and Biotechnology Regulatory

In a highly regulated industry like pharmaceuticals and biotechnology, all phases of corporate life require experienced, sophisticated legal analysis and practical, integrated advice.

At Hogan Lovells, we draw on broad background and deep experience in highly technical regulatory matters to help get ahead of your problems in a creative and practical way. We know not only the details of the law, but also the nuances – because many of our lawyers have worked in the U.S. Food and Drug Administration (FDA) and others have worked with FDA, EMA, and country regulators for years. Several others have worked in industry, which means we also understand your business, the science behind your business, and your marketplace.

Our U.S. team is the largest in the nation dedicated to providing regulatory legal services to the pharmaceutical and biotechnology industries. And because our clients typically operate internationally, our pharma/biotech lawyers in Europe, Asia, and Latin America and the U.S. collaborate closely to provide integrated advice across the globe. And when issues overlap with other disciplines, such as intellectual property, litigation, or health care compliance, we reach across the firm to tap the needed experience. We work seamlessly to provide integrated advice that is calibrated to your business needs across the globe and across disciplines.

Our services are as varied as the challenges you face. We offer timely, effective counsel on matters that include product development, product testing, approval standards, post-approval compliance, and the science, regulation, and policy driving development of next- generation products. Our lawyers concentrate on specific areas of the law, such as advertising, manufacturing compliance, regulatory exclusivities, over-the-counter (OTC) products, pharmacovigilance, and controlled substances.