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EU Registration Strategy for pharmaceutical and biotech companies.

Successfully launching a medicine in Europe requires a strategic approach to regulatory planning.

At AzurBio Consulting, we specialize in helping international pharmaceutical and biotech companies navigate the European regulatory environment and develop tailored EU registration strategies for their medicinal products.

Our goal is to simplify access to the European market and guide clients through every step of the registration and approval process.

Why EU Registration Strategy Matters

The European Union (EU) is one of the world’s largest pharmaceutical markets. However, accessing this market requires full compliance with a complex, multi-country regulatory system.

Foreign companies must understand how to interact with EU regulators, fulfill legislative requirements, and plan clinical development and market access accordingly. A well-defined EU registration strategy helps you:

  • Choose the optimal regulatory pathway (centralised, decentralised, or national procedure)
  • Plan compliant clinical development programs aligned with EU requirements
  • Anticipate submission timelines, dossier structure (CTD), and data needs
  • Coordinate post-approval requirements and market launch

AzurBio’s consulting services provide foreign companies with expert insight into European regulatory expectations. We help streamline your EU drug approval process, saving time and resources while increasing your chances of success.

What Countries Are Included in an EU Drug Approval?

Understanding the reach of EU marketing authorisations is crucial when entering the European market. A medicine approved under the EU centralised procedure is valid in all 27 EU Member States, plus Iceland, Liechtenstein, and Norway – countries that are part of the European Economic Area (EEA). This system enables simultaneous access to nearly 30 countries through one application.

Foreign companies can benefit greatly from this harmonised framework. However, not all products are eligible for the centralised procedure. AzurBio helps determine the most appropriate registration strategy based on your product’s classification, therapeutic indication, and business goals.

Where the centralized route is not mandatory, we advise on the best registration route for your products, which can also be the decentralized procedure (DCP), mutual recognition procedure (MRP), or national pathways, depending on your target markets.

Our EU Regulatory Strategy Services

At AzurBio, we provide comprehensive EU regulatory strategy consulting to help clients prepare their product for successful entry into the European market. Our services include:

Regulatory Pathway Assessment

We evaluate your product’s profile to recommend the most efficient EU registration route. This includes:

  • Gap assessment of your current dossier to comply with EU requirements
  • Centralised procedure (CP) eligibility assessment
  • CP/DCP/MRP strategy planning
  • Early access procedure feasibility studies

Scientific Advice & Early Engagement

We support you in preparing for your briefing package and interactions with European regulatory bodies such as:

  • EMA scientific advice
  • National competent authority consultations
  • EU HTA Joint Scientific Consultations (JSC)

Early dialogue with regulators improves development alignment and de-risks future submissions.

Dossier Strategy and Preparation

We help plan your Common Technical Document (CTD), ensuring compliance with European standards. Our team advises on:

  • Regulatory data requirements (quality, non-clinical, clinical)
  • Module structure and full administrative content expectations
  • EU HTA Joint Clinical Assessment (JCA)
  • Documentation for post-approval variations, renewals, and life cycle management

Product Registration Project Management

Our consultants manage the full EU registration process, coordinating:

  • Submission strategy and timelines
  • Presubmission meetings preparation and organization with Health authorities
  • EU regulatory submissions (e.g., EMA, national portals)
  • Communication with authorities during review procedures
  • Linguistic review procedure for centralized route
  • Anticipation and preparation of your local requirements at local level for your launch

We act as an extension of your regulatory team, especially valuable for companies without a European affiliate.

Post-Approval Compliance & Market Readiness

Beyond approval, we support:

  • Pharmacovigilance system setup and compliance
  • EU labelling and packaging conformity
  • Risk management plans, local educational materials and PSUR/PBRER coordination and submission
  • Local requirements for launch (local code, seruialisation, registration in dictionnaries…)

AzurBio ensures that your product is not only approved but ready for successful European market entry.

Why Partner with AzurBio?

AzurBio Consulting offers:

  • Deep knowledge of EU regulatory requirements and beyond (FDA, TGA, SwissMedic, MHRA…)
  • A proven track record with European submissions and rest of the world
  • Strategic guidance tailored to your business model
  • Transparent project planning and efficient execution

Conclusion

Our consultants have hands-on experience working with the European Medicines Agency (EMA), national competent authorities, and EU-wide initiatives. Whether you’re a biotech launching your first product or a global pharmaceutical firm expanding your EU footprint, we deliver personalized strategies that meet your goals.

Get Started with Your EU Drug Registration Strategy

Entering the EU pharmaceutical market is a major milestone for any life sciences company. Let AzurBio help you build a successful EU regulatory roadmap that ensures compliance, accelerates approval, and prepares your product for market access across Europe.

Contact us today to discuss your product and how we can help you develop and implement an EU registration strategy tailored to your success.