Life Sciences & Healthcare Regulatory
Arnold & Porter's renowned Life Sciences and Healthcare Regulatory practice is unique in providing a fully integrated team focused on delivering comprehensive and sophisticated assistance to clients in all areas of life sciences product and healthcare regulation. Our clients include manufacturers of pharmaceutical, biotechnology, medical device, and diagnostic products; healthcare professionals; universities; and leading trade and professional organizations. We also represent companies in the food, dietary supplement, over-the-counter drug, and cosmetic fields. Our practice supports virtually every aspect of our clients' regulated business activities, including US FDA, EU, UK, and China regulatory strategies; clinical trials; inspections; promotion and advertising; exclusivities; fraud and abuse; pricing; contracting; coverage and reimbursement; domestic and global compliance programs; government investigations; transactional diligence and post-transaction integration; and public policy advocacy.
Decades of Experience: Our global team has handled the most challenging life sciences and healthcare regulatory matters, from high-profile global regulatory investigations to unprecedented strategies for obtaining approval.
Deep Knowledge of Government and Science: Our highly experienced lawyers and other professionals are thought leaders in the field; many have senior government, in-house and corporate professional experience, as well as advanced degrees in diverse scientific and medical fields.
Global in Scope: Our practitioners in the US, Europe, the UK, and Asia routinely handle global regulatory challenges for our clients, from compliance program development to simultaneous regulatory inspections.