Solutions

Expand to Europe

Our EU platform of services, modular, tailored, and built for biotech with a 1st medicine.

Client Specific EU Hubs:

From initial entry to long-term sustainability in the EU ecosystem.

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Pave the Way

Confidently Navigate Your Path to Develop and Register Your First Orphan Product in Europe.

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Boost Access

Accelerate Patient Access in Europe - Fast-Track Your Innovation if Eligible.

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Scale Up

Build and Grow your European footprint. From Pan-European Strategy to Local Success.

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Pave the Way

Confidently Navigate Your Path to Develop and Register Your First Orphan Product in Europe.

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Your Goal

Design the optimal regulatory pathway during drug development and achieve key milestones in the registration process.

Our Solution

  • A dedicated team, who understands the complexities of entering Europe for the first time, to drive progress and keep you on track.

  • A clear, customized EU regulatory & development roadmap aligned with your global plan.

  • Guidance through scientific advice, PIP, ODD, eCTD submission preparation, and registration milestones.
  • Hands-on operational support setup for regulatory readiness and to activate essential EU infrastructure

  • Centralized coordination across internal teams and external stakeholders to keep timelines on track
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Boost Access

Accelerate Patient Access  in Europe. Fast-Track Your Innovation if Eligible.

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Your Goal

Maximize your product’s potential with strategic use of EMA accelerated pathways and regulatory/HTA strategy to speed up approvals and access.

Our Solution

  • A clear assessment of your eligibility for PRIME, CMA,
    or other fast-track routes.

  • A strategy to engage authorities early and effectively.
  • Integrated regulatory + HTA planning to streamline approvals and reimbursement.

  • Experienced partners to manage submissions, advice procedures, and follow-up
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Scale Up

Build and Grow your European footprint. From Pan-European Strategy to Local Success.

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Your Goal

Fast-track your market entry in France by acquiring a fully compliant, ready-to-operate Exploitant structure—enabling immediate regulatory alignment without the delays of building from scratch.

Our Solution

  • A scalable operational footprint and coordination across your target EU markets.

  • Local expertise to navigate country-specific requirements with precision to build your EU presence.
  • Guidance on setting up a compliant, scalable infrastructure.

  • Ongoing support for market optimization and compliance.

Join the Expert Q&A Series

Critical Knowledge. Real Experts. Your Questions.

Get access to concise, high-impact PDFs where our industry veterans distill decades of experience to help you navigate Europe’s complex biotech and pharma landscape.

Each edition focuses on the critical knowledge you need—from regulatory hurdles to post-approval strategy—so you avoid costly missteps and move
forward with clarity.

You’re not just reading—you’re part of the dialogue. Each edition is shaped by questions from our community, and you can submit your own for future
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Looking to enter the EU market?
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