Life Sciences and Healthcare Regulatory
The Arnold & Porter Kaye Scholer Life Sciences and Healthcare Regulatory practice has been recognized by virtually every leading legal publication as a leading practice in the field, including:
- Chambers Global 2008-2017 for Life Sciences.
- Chambers USA 2005-2016 for Life Sciences (Nationwide) and Healthcare: Pharmaceutical/Medical Products Regulatory (Nationwide).
- Chambers UK 2013-2016 for Life Sciences; Life Sciences: Product Liability; and Life Sciences: Regulatory (Band 1).
- LMG Life Sciences Guide 2012-2015 for Non-IP Litigation & Enforcement: Government Investigation/Fraud & Abuse.
- LMG Life Sciences Guide 2015 Life Cycle Firm.
- The Legal 500 US 2013-2016 for Healthcare: Life Sciences.
- Law360 Healthcare Practice of the Year (2016).
The Arnold & Porter Kaye Scholer Life Sciences and Healthcare Regulatory Practice is unique—unlike other firms, which typically scatter these capabilities across various siloed practices, we maintain a fully integrated team focused on providing comprehensive assistance to our clients in all areas of life sciences product and healthcare regulation. Our clients range from global enterprises to early-stage start-ups and include manufacturers of pharmaceutical, biotechnology, medical device and diagnostic products, healthcare professionals and other providers of health care services, universities, and some of the leading trade and professional organizations and societies. We also do extensive work for companies in the food, dietary supplement, over-the-counter (OTC) drug and cosmetic fields.
Our practice supports virtually every aspect of our clients' regulated business activities, including development of US FDA and EU 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. We cross-train all of our lawyers to recognize the complex array of issues that impact the business of our life science and healthcare professional and provider clients to ensure that our advice and assistance is practical and seamless.
Our team is comprised of an array of highly experienced lawyers and other professionals, many with senior government, in-house, and corporate professional experience, as well as attorneys who hold advanced degrees in diverse areas such as neurobiology, endocrinology, nursing, bioethics, biophysics, biochemistry, and biotechnology.
- Administrative and EU Regulatory Litigation
- Controlled Substances
- Coverage and Reimbursement
- Diagnostic Imaging
- Drugs and Devices - Food and Drug Administration Regulatory Counseling
- EU Life Sciences
- FDA and Healthcare - Related Legislation and Congressional Investigations
- FDA Compliance and Enforcement
- Fraud and Abuse and False Claims Matters
- Healthcare and Life Sciences Product Investigations and Enforcement
- Healthcare Privacy and Data Security
- Healthcare Professionals, Medical Societies and Healthcare Associations
- Hospitals, Health Systems and Clinically Integrated Healthcare Delivery
- Internal Investigations, Audits and Self Disclosure
- Mobile Health and Emerging Technologies
- Pharmaceutical Pricing and Contracting
- Regulation of Clinical Research
- Transactions, Diligence and Integration
Regulatory: Life Sciences/Pharmaceuticals (Europe-wide) (2014-2017)
Healthcare: Pricing & Reimbursement – Recommended (2016)
Life Cycle Firm (2013-2015)
Regulatory Healthcare: Pricing & Reimbursement (2012-2014)
Regulatory FDA: Medical Devices (2013-2014)