European Union Life Sciences Regulatory

Latham’s comprehensive European Union life sciences practice brings deep and far-reaching regulatory experience with on-the-ground capabilities in Brussels and key EU member states.

We help European and global pharmaceutical, biotech, and medical device companies, from startups to multinationals, establish a global footprint for their medical technologies. Our team skillfully guides clients through the cross-border regulatory and economic considerations of conducting global clinical trials and commercializing life sciences technologies in Europe.

Latham advises life sciences companies throughout the product lifecycle, from designing effective and efficient clinical and pre-clinical testing programs to securing patent and regulatory exclusivity, as well as reimbursements. Following product launch, we counsel on compliance relating to product manufacture, marketing, distribution, and safety.

We counsel clients on post-market compliance with EU requirements, including recalls and other safety-related actions, and governmental investigations and enforcement.  We help clients develop and implement global clinical trial strategies designed to support European approvals, and facilitate compliance with applicable international laws and regulations.

The EU team works closely with healthcare and life sciences-focused colleagues in the US and around the world to ensure compliance and market access across key global jurisdictions. Whether clients are seeking parallel approval from the US Federal Drug Administration, designing a product with global data privacy and patent implications, or pursuing cross-border investments, Latham’s provides integrated and efficient counsel to meet every need.