WASHINGTON—Who's Who Legal recognized Covington as its Life Sciences Regulatory Firm of the Year. Each year Who’s Who Legal presents awards to the individuals and firms that have performed exceptionally well in their research.
Covington offers one of the largest and most comprehensive life sciences industry-focused practices in the world. The firm's clients, spanning all industry sectors and ranging from startup ventures to multinational corporations and trade associations, trust Covington with their most challenging business problems. Covington’s pre-eminent regulatory practice is at the core of the firm’s life sciences group. The firm provides regulatory, compliance, and market access advice to a majority of the world’s pharmaceutical, medical device, and biotechnology companies, including nearly all multinational pharmaceutical and device companies, as well as emerging and mid-sized companies.
Covington's practice covers every facet of medical product regulatory law in the U.S. throughout the life cycle of FDA-regulated medical products, from clinical trials and product development through FDA review and approval, product pricing and market access, and post-launch requirements, including pharmacovigilance, risk evaluation and mitigation strategies (REMS), sales and marketing, compliance with Good Manufacturing Practices and Quality System Regulations, and other post-approval activities. Our lawyers have also been actively involved in all major legislative initiatives that have affected pharmaceutical and medical device regulation.
In Europe, Covington advises extensively on pharmaceutical, medical device, food and cosmetics regulatory issues. In the pharmaceutical sector, it advises on regulatory procedural issues, pharmaceutical pricing and reimbursement; life-cycle management, including regulatory data, orphan, and pediatric exclusivity, GXP compliance, the ongoing EU pharma law review, among many others. The firm is active in public law litigation in the EU and national courts. In the device sector, the firm's lawyers are also currently advising clients on the new regimes established by the EU Medical Devices Regulation and the EU In Vitro Diagnostics Medical Devices Regulation, as well as the new UK-specific regulatory regime for medical devices, introduced in 2023.
Covington also has decades of collective experience in Mainland China and throughout the Asia Pacific region, and serve as advisors or advocates on life sciences regulatory projects and transactions presenting novel and complex issues of pan-Asian scope and importance. The firm advises clients on numerous aspects of the drug and medical device regulatory processes before the National Medical Products Administration (NMPA), including pre-clinical and clinical development, registration strategies, intellectual property issues, pharmacovigilance, GxP inspections, and other post-market compliance issues. It also advises company and industry association clients on notice and comment and other aspects of legislation and rulemaking processes related to amendments of drug and device regulatory regimes in China.
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