Healthcare & BioTech

Life Sciences Advisory Across the Atlantic

The healthcare and biotechnology sectors present unique challenges for cross-border expansion. Regulatory pathways for drugs, medical devices, and digital health solutions differ fundamentally between the FDA in the United States and the EMA in Europe. Reimbursement systems, clinical trial requirements, intellectual property protections, and market access strategies vary significantly by jurisdiction. Success requires not just scientific excellence but deep regulatory knowledge and strategic commercial planning.

Crossover Consulting has advised more than 65 healthcare and biotech companies on transatlantic strategy, from early-stage biotech firms seeking international investors to multinational pharmaceutical companies pursuing cross-border acquisitions. Our healthcare practice combines regulatory expertise with commercial acumen and capital markets experience to provide integrated advisory that addresses the full spectrum of challenges facing life sciences companies operating across borders.

We understand the specific dynamics of healthcare markets in both the US and Europe. The US market offers higher pricing potential and faster commercialization timelines but demands significant investment in market access and payer relations. European markets provide access to universal healthcare systems and large patient populations but require navigating country-by-country reimbursement negotiations and health technology assessment processes. Our advisory helps clients develop market entry strategies that account for these differences and maximize commercial potential in each market.

Regulatory Strategy: FDA, EMA, and Beyond

Navigating dual regulatory pathways is among the most complex challenges in transatlantic healthcare. We help clients develop parallel or sequential filing strategies that optimize development timelines and resource allocation. Our regulatory advisory covers pre-submission strategy, clinical development planning, manufacturing compliance, and post-market surveillance requirements across jurisdictions. For medical devices, the transition to the EU MDR framework has created particular complexity that our team helps clients navigate efficiently.

Our capital markets expertise is particularly relevant in healthcare and biotech, where capital intensity is high and investor expectations are sector-specific. We connect companies with healthcare-focused venture capital firms, life sciences private equity funds, and strategic investors who bring both capital and industry expertise. Our team has facilitated more than $320 million in capital placements for healthcare and biotech companies across the Atlantic.

M&A in Life Sciences

Cross-border M&A in healthcare requires specialized knowledge of regulatory transfer processes, manufacturing site qualifications, IP portfolio assessment, and pipeline valuation. We have advised on 22 healthcare M&A transactions, helping acquirers evaluate regulatory assets, assess pipeline risk, and plan for post-merger integration across regulatory jurisdictions.