For European companies entering the United States, we advise on:

• Federal regulatory environment

• FDA and CMS policy dynamics

• Congressional and Executive Branch engagement

• Reimbursement and 340B landscape

• Trade and national security review exposure

We help companies align market entry with federal policy realities.

We advise European and global companies entering or expanding within the United States on regulatory positioning, federal and state policy dynamics, and market access strategy.

The U.S. regulatory environment is shaped by federal agencies, state regulators, Congressional priorities, reimbursement frameworks, technology oversight, and national security considerations. Market entry requires alignment not only with statutory requirements, but with evolving policy momentum and enforcement posture across multiple jurisdictions.

Our work includes:

• Federal and state regulatory landscape assessment

• FDA, CMS, and state agency policy environment analysis

• Technology and emerging innovation regulatory advisory

• Congressional and Executive Branch engagement strategy

• Reimbursement and market access environment mapping

• Trade and tariff exposure review

• National security and foreign investment policy analysis

• Policy risk advisory for cross-border growth and capital deployment

We help leadership teams anticipate regulatory fragmentation, political headwinds, technology governance developments, and enforcement trends before scaling operations or committing capital.

We provide strategic regulatory and government affairs advisory services informed by U.S. federal and state experience.