Pharmaceuticals & Medical Devices

Operating in a space where regulatory precision, clinical credibility, and political navigation intersect, Transatlantic Strategy Group helps pharmaceutical and medtech companies succeed across regulated markets.

Our firm provides support in:

Market expansion and distribution strategy across the EU, including regulatory alignment and product registration.

Medical device compliance with MDR/IVDR in Europe, and strategic navigation of FDA and transatlantic regulatory pathways.

Advisory on cross-border R&D partnerships, government engagement, and health policy alignment.

Support for clients seeking to localize manufacturing in response to supply chain security, resilience, and strategic autonomy concerns.

In light of the evolving geopolitical landscape, including looming sector-specific tariffs and trade tensions impacting pharmaceuticals, we help companies — especially non-U.S. firms — develop strategic plans to mitigate exposure. This includes preparing for shifting regulatory environments, local manufacturing requirements, and supply chain diversification to offset tariff risks and maintain competitive market access.

We’ve advised leading firms such as Gammex RMI, Schwarz Pharma, and Stada — a major German generics manufacturer — engaging in strategic dialogue around the intersection of public health systems, innovation, and transatlantic trade. For Stada, we addressed market entry and expansion challenges related to their sales through non-proprietary channels, optimizing their approach in a complex competitive landscape. Our close ties to stakeholders in the European Commission, German ministries, and U.S. health and trade agencies allow us to facilitate trusted, high-level access.