Life Sciences

Steptoe’s life science practice advises clients with regard to laws and regulations pertaining to drugs, medicinal products, and medical devices in the US and Europe. We have in-depth knowledge of FDA’s regulatory framework related to human and animal drugs and medicinal products. We assist both domestic and foreign drug manufacturers, importers, and distributors in all aspects of manufacturing, marketing, and post-marketing safety issues.

Our extensive knowledge and experience working with FDA. FTC, TTB, and DEA enables us to proactively advise clients on regulatory issues. Further, our team regularly assist clients on regulatory strategies for placing new and/or modified medical devices on the market, including demonstrating in coordination with our scientific staff that the required safety requirements have been met, working with the appropriate authorities to reach resolutions regarding the regulatory status of medical devices, as well as experience in successfully defending clients in enforcement actions. We work closely with the relevant industry associations in the United States and Europe, we keep abreast of the most current policy and regulatory issues affecting the industry.

Biotechnology is at the core of Steptoe’s life sciences practice. We assist clients in developing and marketing genetically modified (GM) plants, seed, food, and feed (and the complementary agricultural chemicals that many of them supply). Steptoe is counsel to companies supporting some of the most high-profile genetically modified products on the market. We also advise regional and international trade associations operating in the agribusiness sector. In addition to these “green biotech” applications, we have a strong body of experience with “white biotech” industrial applications. The politically-charged regulatory framework in the European Union has the potential to create barriers to market access for our clients, and Steptoe lawyers work to assist them in navigating this complex landscape.