Search
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.
Instrumental in persuading FDA to change longstanding regulatory position on awarding exclusively to fixed-dose combination products, benefiting Gilead's products in HIV and Hepatitis C fields.
Convinced FDA to give 5-year exclusivity to fixed dose combination products that include a new chemical entity and a previously approved active ingredient.
Successfully sued FDA to overturn denial of orphan drug exclusivity.
Help respond to FDA Form 483 observations, warning letter to close out FDA investigation.
Negotiate settlement of FDA lawsuit alleging cGMP noncompliance.
Conduct internal investigation of promotional practices and help develop and implement enhanced practices.
Audit clinical trial study reports to ensure compliance with adverse event reporting obligations.
Advise on FDA/DEA interplay during drug development and approval process, scheduling under CSA.
Conduct due diligence of FDA and EU regulatory law for IPO.
Advising a research-based pharmaceutical company with respect to a government demand for price reductions under its federal contracts with the U.S. DVA.
Advising private equity firm on FDA regulatory aspects of potential investments.
Partner
Washington, D.C.
Partner
Washington, D.C.
Partner
London
Partner
Amsterdam
Partner
Mexico City
Band 1 for Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia
Chambers USA
Band 1 for Life Sciences: Regulatory/Compliance
Chamber USA
Band 1 in Life Sciences
Chambers Global
