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 U.S. 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.
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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.
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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.
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Global in Scope: Our practitioners in the U.S., Europe, the UK, and Asia routinely handle global regulatory challenges for our clients, from compliance program development to simultaneous regulatory inspections.
Focus Areas
- Clinical Research
- FDA Strategy, Compliance and Enforcement
- Pharmaceutical Product Pricing and Contracting
- Coverage and Reimbursement
- Compliance and Fraud and Abuse Counseling
- Life Sciences and Healthcare Investigations and Litigation
- Life Sciences and Healthcare Due Diligence and Integration
- European Union/UK Product Life Cycle Regulation
- China Life Sciences Regulation and Compliance
- Healthcare Providers, Suppliers and Delivery Systems
- Healthcare Government Investigations
- Healthcare Privacy and Data Security
- Virtual and Digital Health
- Diagnostics and Clinical Laboratories
Key Contacts
Related Services
Recognition
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Chambers UKLife Sciences – UK-wide: Band 1 (2024)
Life Sciences: Product Liability – UK-wide: Band 1 (2024)
Life Sciences: Regulatory – UK-wide: Band 1 (2024) -
The Legal 500 USHealthcare: Life Sciences (2023)
Healthcare: Service Providers (2023) -
Chambers EuropeLife Sciences – Europe-wide (2024)
Life Sciences/European Law – Belgium (2024)
Life Sciences – Netherlands (2024) -
Chambers GlobalLife Sciences – Global-wide (2024)
Life Sciences – Europe-wide (2024)
Life Sciences and Pharmaceutical Sector: International and Cross-Border – UK (2024)
Life Sciences and Pharmaceutical Sector: International and Cross-Border – USA (2024)
Life Sciences: Regulatory/Compliance – USA (2024) -
Chambers Greater China RegionLife Sciences: International Firms – China (2023)
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The Legal 500 Asia-PacificLife Sciences and Healthcare: Foreign Firms – China (2023)
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Law360"Practice Group of the Year" (2022)
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LMG Life Sciences GuideRegulatory Healthcare: Pricing and Reimbursement (2022)
Regulatory FDA: Pharmaceutical (2022)
Regulatory FDA: Medical Devices (2022) -
The Legal 500 UKIndustry Focus: Life Sciences and Healthcare (2023)
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Chambers USAHealthcare: Highly Regarded – Nationwide (2023)
Healthcare: Pharmaceutical/Medical Products Regulatory – Washington, D.C. (2022-2023)
Healthcare – Washington, D.C. (2022-2023)
Life Sciences – Nationwide, California (2022-2023)
Life Sciences: Regulatory/Compliance – Nationwide (2022-2023) -
Above the Law"Outside Counsel Rankings" Top counsel in Healthcare/Life Sciences (2021)
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Managing Intellectual Property"U.S. Firm of the Year" Life Sciences IP Litigation (2021)
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Chambers Asia-PacificLife Sciences (International Firms) (2021)
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U.S. News & World Report and Best Lawyers"Best Law Firms" FDA Law – Washington, D.C., National (2024)
"Best Law Firms" Healthcare Law – Washington, D.C., National (2024) -
LMG Life Sciences AwardsLife Cycle Firm of the Year - United States (2022-2023)
Regulatory Firm of the Year (2023)
