Through innovative products, pharmaceutical companies are helping people live longer and higher quality lives. To make that happen, you need legal services that meet your regulatory, transactional, litigation and intellectual property needs. Faegre Baker Daniels lawyers are veterans of the world's largest pharmaceutical companies and the Food and Drug Administration, and they understand how to provide for your needs.
Corporate and Transactional
We advise on public and private financing, mergers, acquisitions, joint ventures, strategic alliances, licensing, product development, and supply and distribution arrangements in the pharmaceutical industry. For emerging companies, we serve as outside general counsel. We manage your outsourcing needs in areas such as formulation development, clinical trials, and other contract research, manufacturing and marketing services.
Our team counsels U.S. and international pharmaceutical companies on protecting, developing, commercializing and enforcing intellectual property rights. The processes of filing and registering patents, trademarks and domain rights in the U.S. and abroad are complex. We oversee these processes on your behalf so you can focus on creating pharmaceuticals. We also assist in developing and managing IP portfolios, conducting due diligence assessments and navigating third-party patents.
Our FDA team can guide your drug through development, production and marketing while navigating numerous regulations. We advise on regulatory matters for prescription and over-the-counter (OTC) drug products, OTC switches, and behind-the-counter issues. We counsel on fixed-dose combination products and help you prepare for advisory committee meetings. We support your company in seeking user fee waivers and in all other interactions with FDA. We advise on orphan drug issues and exclusivity and help you obtain the patent term extension to which you are entitled. Our professionals also have significant expertise in labeling negotiations and review of promotional materials.
Inspections and Enforcement
Allegations that you have violated the law can adversely impact your employees, customers, finances, stock price and future prospects. We develop and implement effective compliance programs, conduct independent internal investigations and manage crisis communications during allegations. We also represent pharmaceutical companies on fraud and abuse matters. During FDA inspections and enforcement actions, we advocate for you and negotiate with regulatory authorities.
Whether you are facing mass tort, antitrust, commercial class action, or intellectual property litigation, we provide counsel that helps you weather the storm and emerge safely on the other side. We are nationally recognized for our product liability defense practice in the pharmaceutical industry.