Areas of Focus
Our firm represents clients across the global pharmaceutical and biotechnology industry, advising on the full array of transactions while also delivering zealous advocacy in regulatory matters and investigations and at trial. With offices in key pharmaceutical and biotechnology hubs across the United States, Asia Pacific, Europe, and the Middle East, we are where our clients are around the world, advising on:
- M&A, licensing and collaboration, joint ventures, and financing agreements, as well as commercial contracts and distribution and R&D agreements
- Crisis management, consumer class actions, product liability, patent infringement and lifecycle, post-M&A and contract litigation, white collar litigation, and government and internal investigations
- Clinical trial and IRB strategies, protocols, and consents
- FDA NDA/ANDA/BLA/351k approvals and cGMP and enforcement matters, including 483s, recalls, and warning letters
- Drug pricing and reimbursement
- Patent prosecution and protection
- International regulatory advice and life sciences compliance
Medical device law is being dramatically reconfigured in response to evolving technology. We represent top medical device companies, delivering seamless regulatory, IP, transactional, and litigation counsel to a range of medical device developers, manufacturers, wholesalers, distributors, and tech companies. We provide advice on:
- FDA Premarket advice involving Section 510(k) notifications, PMAs, and IDE and HDE submissions, panel reviews, scientific disputes and appeals, and device modification analyses
- Post-market counsel, including product marketing strategies, compliance, product liability exposure, medical device reporting, cGMPs, recalls, and field corrections
- Enforcement actions, including FDA Form 483 and warning letter responses, import/export and consent decree issues
- M&A, licensing, and collaboration, financing agreements and commercial supply, distribution, and other contracts
- Crises management, mass tort and class actions, product liability, and commercial contract challenges
- Patent prosecution and protection, trade secret, and trademarks
- Antitrust, labor and employment, litigation, and tax issues
