About Europa Advisors

Who We Are

Europa Advisors helps life sciences and technology companies establish and expand operations across Europe. From opening laboratories and manufacturing facilities to launching clinical trials, standing up data centers, and navigating the regulatory and legal landscape, we provide end-to-end advisory services for companies making the transatlantic move.

Our team brings deep experience across the operational realities of EU market entry: site selection, HR and employment law, regulatory compliance (including GxP, NIS2, and the EU AI Act), IT infrastructure, and partnerships with Europe’s leading science and technology hubs. Whether you’re a biotech scaling into EU clinical operations or a technology vendor building a European presence, Europa Advisors turns strategy into execution.

We deliver this through a comprehensive, 12-pillar service architecture that bridges the gap between US innovation and European execution. Our multidisciplinary approach ensures that every facet of your expansion, from Funding & Capital (VCs, angel investors, and EU grants) to Regulatory Compliance (FDA-to-EMA transitions and submission reviews), is managed through a single, interconnected framework.

By integrating Legal and IP strategy with Development and Outsourcing (CMOs/CROs), we handle the heavy lifting of due diligence and international corporate structuring. Beyond strategy, we manage the operational “last mile,” including Real Estate, Accounting, and Digital Transformation. With Subject Matter Experts across every line of service, Europa Advisors ensures that your move to Europe is not just a relocation, but a seamless integration into the continent’s premier science and technology ecosystems.

What We Do

We help pharma and biotech companies, software vendors, and investors understand what operating in EU-regulated environments actually requires — and close the gap between where they are and where they need to be. That means regulatory bridging, computerized system validation under Annex 11, AI governance, technical due diligence, and GDPR in life sciences contexts.

See our full service listing for detail on each practice area.

Why We Do It

The transatlantic regulatory gap costs companies time and money — not because the requirements are unreasonable, but because they are routinely misunderstood. FDA and EMA share common goals around patient safety and data integrity, but the frameworks differ in ways that matter operationally. We exist to close that gap before it becomes a compliance problem.

How We Work

We work from the actual regulatory texts — EU GMP Annexes, EMA guidelines, the EU AI Act, GDPR — not summaries of summaries. When we tell you something is required, we can show you where. When we tell you something is risk-based judgment, we say that too.

Our engagements are scoped to what you actually need. We document what needs to happen before executing it, respect existing systems before suggesting replacements, and deliver guidance you can adapt to your context.

Document what you’re going to do. Do what you document. Generate the evidence you did it.

The Team

Kevin Shea — US Practice Lead

Ilaria — EU Practice Lead

We also work with a network of specialist partners. See our Partners page for more.