EU Strategy

Agile support to run your studies in Europe 
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EU Expansion

Expand your clinical programme confidently into Europe with streamlined regulatory pathways, operational readiness, and scientifically robust study models. hVIVO provides an integrated suite of services tailored for US sponsors seeking smooth EU/UK entry, accelerated study start-up, and long-term portfolio optimisation.

 

 

US sponsors face unique challenges when expanding into Europe — from regulatory translation and local representation to funding, site strategy, and portfolio continuity. hVIVO provides a fully integrated US-to-EU expansion framework, combining regulatory, scientific, and operational support with a strong European delivery footprint. Our goal is to reduce friction, accelerate timelines, and establish a scalable foundation for your long game in Europe.

EU Expansion Support

Integrated EU expansion support that streamlines regulatory translation, accelerates study start‑up, and builds a scalable foundation for long‑term European success.

  • 35+ years’ experience in infectious disease & early-phase clinical delivery
  • Trusted partner for US & Asian biotech expansion into EU/UK
  • Industry-leading human challenge models and scientific expertise
  • Faster execution enabled by agile governance & rapid project start‑up
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Why Consider hVIVO?

Deep expertise supporting US biotech and pharma entering EU/UK markets


Proven processes that underpin successful clinical readiness
Ability to optimise portfolio pacing during slow periods
Unique scientific assets, including human challenge models for early efficacy detection

Owned clinics and strong EU site/network partnerships

Agile, responsive operational model built for speed and scientific precision 

hVIVO EU Expansion Solution Includes:

EU Site & Network Strategy

Owned sites in Germany and the UK

Grant & Funding Guidance

Guidance to help you secure the grants and funding you need

 

Human Challenge Trials

 For Universal Efficacy Signals

Portfolio Pacing

For slower periods

IND-IMPD Transfer

Streamlined support to convert your IND into a compliant EU IMPD

Legal Representation

 For US Companies in EU/UK 

Our EU Expansion Support is For:

  • US & Asian biotechs preparing to expand into Europe
  • US & Asian pharma sponsors needing streamlined regulatory translation
  • Companies planning multi-site EU studies
  • Sponsors seeking early efficacy signals via challenge trials
  • Teams needing local legal/regulatory representation
women presenting to room

FAQs

 EU regulatory, operational, and site landscapes differ significantly from the US. 

  Yes, local legal representation is required. 

 Yes, they provide rapid efficacy insights. 

 Timelines range from 4–12 weeks. 

Get Ahead Today

Contact our Team Expand Your Studies in Europe

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