A Complete Roadmap for US Biotechs Entering the EU/UK Market
About this whitepaper
Breaking into the EU/UK market is one of the biggest steps a US biotech can take, and one of the most misunderstood. Many companies assume their FDA-approved data package and development approach will transfer over with minimal adjustment. In practice, that assumption leads to delays, costly rework, and regulatory risk that could have been avoided.
This whitepaper, written by Angeles Escartí-Nebot, lays out a clear, practical roadmap for US biotechs at any stage of European expansion. It covers the structural differences between the US and EU regulatory systems, the most common pitfalls, and the strategic decisions that determine whether market entry runs smoothly or gets derailed.
Whether you''re evaluating your first EU submission or trying to get ahead of operational requirements like QP oversight and pharmacovigilance, this guide gives you the framework to plan with confidence.
What you''ll learn
- Why EU market entry is not a continuation of your FDA pathway, and what that means for your development program
- How to choose between the EMA centralised procedure and national routes, and when that decision can make or break your timeline
- What FDA-ready data packages typically miss when it comes to EU CMC expectations, clinical design, and dossier formats
- Why the UK can be a smart, lower-friction entry point before tackling the broader EU framework
- What operational infrastructure you need in place before approval, including pharmacovigilance systems, QP oversight, and MAH setup, and why leaving this to post-approval is a risk you don''t want to take