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Accelerate Your Market Entry into Europe - QbD Group-1-1

Bring Your Biotech to Europe and the UK with Confidence

Integrated regulatory, quality, and operational expertise to turn US progress into European market readiness

European expansion requires more than extending an FDA pathway. We help you translate US development momentum into a compliant, strategically aligned, and executable EU and UK entry plan.

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End-to-End Support for EU & UK Market Entry

Expanding into Europe and the UK presents significant opportunities for US companies, but it also brings regulatory and operational complexity that goes beyond a simple extension of the FDA pathway. Through our end-to-end European market entry expertise, we help you:


  • Translate FDA-driven clinical and regulatory momentum into a structured, compliant, and achievable EU/UK expansion plan

     

  • Execute regulatory submissions and interactions with EU and UK authorities

     

  • Implement quality and safety systems necessary to operate seamlessly in the market

 

Our integrated approach ensures that your European expansion is not only feasible but strategically aligned and operationally ready.

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How to Integrate Outsourced QA into Your QMS Without Losing Control QbD Group

 

Expanding into Europe Demands Early Strategic Alignment

Successfully entering the EU and UK markets requires coordinated planning across regulatory, quality, and operational functions from the outset. While US companies often have strong development foundations, European requirements introduce additional layers of procedural, compliance, and structural considerations that influence feasibility, timelines, and execution.

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Divergent Regulatory Pathways

EU and UK regulatory frameworks follow different procedural logics, review timelines, and authority interactions than the US.
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FDA Documentation Adaptation

US-focused clinical and regulatory documentation often needs structural and strategic modifications to meet EU/UK scientific and procedural expectations.
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Extended Compliance Requirements

Obligations start earlier and continue beyond approval, including pharmacovigilance, QA oversight, and MAH responsibilities.
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Fragmented Support Across Functions

Siloed RA, QA, QP, PV, and MAH support increases coordination effort and execution risk.
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Limited Local Infrastructure

Authority interactions, submissions, and operational readiness can be harder to control without established European infrastructure.

A Structured, Scalable Pathway from US Readiness to EU and UK Market Entry

We guide US companies through every stage of European expansion with a clear, phased approach that aligns strategy, regulatory execution, and operational readiness.

Align on the EU and UK Development Path
We clarify your product ambition, target markets, and clinical milestones to create a practical EU and UK roadmap grounded in European realities.

Step 1

Identify Gaps and Priority Actions
Through a focused assessment, we pinpoint gaps between US and EU requirements across strategy, evidence, CMC, quality, and safety, producing a prioritized plan with realistic timelines.

Step 2

Build Foundations and Execute Critical Workstreams
QbD Group coordinates regulatory submissions, GMP readiness, and procedural governance, ensuring EU and UK milestones progress predictably.

Step 3

Scale Support as EU and UK Activities Grow
As your program evolves, our support scales with you, providing additional expertise when needed without requiring premature EU infrastructure.

Step 4

Accelerate Your Market Entry into Europe - QbD Group-1

QbD Group combines strategic EU pathway design with hands-on regulatory, quality, and safety execution, enabling US companies to enter and operate in Europe with one integrated partner.

Key Benefits

Clarity, Control, and Confidence in European Expansion

Expanding into Europe requires more than regulatory approval. It demands structure, alignment, and operational control. Our integrated approach ensures your EU and UK entry is strategically grounded, execution-ready, and built for sustainable market presence.

Structured EU and UK Pathway

Structured EU and UK Pathway

Strategic conversion of FDA-focused documentation into EU- and UK-ready submission content, reducing rework and avoiding unnecessary delays.

Optimized Documentation Transition

Optimized Documentation Transition

Strategic conversion of FDA-focused documentation into EU- and UK-ready submission content, reducing rework and avoiding unnecessary delays.

Coordinated Regulatory Management

Coordinated Regulatory Management

Structured handling of submissions and authority interactions across EU and UK systems to maintain momentum and procedural clarity.

Sustainable Operational Readiness

Sustainable Operational Readiness

Implementation of PV, QA oversight, and MAH frameworks to enable compliant, stable, and long-term European operations.

Integrated Cross-Functional Delivery

Integrated Cross-Functional Delivery

Unified management of strategy, regulatory execution, quality, and safety to reduce fragmentation and lower expansion risk.

Why QbD Group?

  • Integrated European expertise across regulatory, quality, QP, PV, and MAH, reducing fragmentation during EU and UK expansion.
  • Hands-on experience navigating European procedures and authorities, grounded in practical execution, not just regulatory theory.
  • Execution-driven support combining strategy and delivery, ensuring submissions, systems, and governance move forward together.
  • A scalable partnership model for US companies entering Europe, providing early structure while supporting long-term market presence.
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Full lifecycle support

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Scalable expertise

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Global team of 600+ experts

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20+ years of experience

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Partner with QbD Group to accelerate your US company’s entry into Europe and the UK. Fill out the form and our experts will help you align strategy, navigate regulatory complexity, and build a structured, execution-ready European expansion plan.
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