In today's rapidly evolving life science and healthcare landscapes, pharmaceutical and biotechnology companies face unprecedented opportunities and challenges. Morgan Lewis provides strategic legal solutions that empower innovators to understand and leverage complex regulatory environments, protect intellectual property, and bring life-changing treatments to market on a global scale.
Safeguarding Innovation
Our multidisciplinary team supports clients across the entire spectrum of drug development and commercialization, including advising on and guiding clients through:
- Regulatory compliance, such as FDA and international regulatory processes including clinical trials, drug approvals, and adherence to evolving standards
- Developing comprehensive intellectual property strategies to protect and enforce patents, trademarks, and trade secrets crucial to pharmaceutical and biotech innovation
- A wide variety of business transactions, including structuring and negotiating R&D collaborations, licensing agreements, M&As, and joint ventures that drive growth and expand market share
Responding to Market Challenges
We anticipate potential hurdles and advise on proactive strategies to address:
- Quality assurance, including manufacturing risk evaluation and mitigation, inspections, recalls, and compliance with the Drug Quality and Security Act
- Crisis management, where we render swift, decisive counsel in the event of product quality issues, recalls, regulatory investigations, and other critical market access challenges
- Litigation and dispute resolution, including vigorously defending clients in patent disputes, product liability and class actions, and antitrust and commercial litigation in the United States and around the world
Driving Commercial Success
Our team supports the business objectives of pharmaceutical and biotech companies at all stages of development. We guide clients through:
- The complexities of market access, such as drug pricing, reimbursement, and market entry strategies and the implications of the Inflation Reduction Act
- Entity formations, IPOs, and restructurings in order to secure funding for groundbreaking research and innovation
- Sustainability initiatives and emerging ESG requirements that bolster transparent, responsible business practices
By combining deep industry knowledge with broad and thorough legal capabilities, Morgan Lewis empowers pharmaceutical and biotechnology clients to focus on what matters most: developing innovations and products that advance human health and well-being.