Accelerate your market entry into Europe

Expand your life science business into the European market

Whether you need regulatory guidance, GMP compliance, or batch release support, QbD Group is here to help you navigate the highly regulated European market.

Thanks to our end-to-end solutions, you can confidently manage the complexities of the market and ensure your products reach patients efficiently.

Our solutions

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Why enter the EU market?

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High potential market

It's the second largest market in the world with more than 500 million patients
There are 30+1 countries with free circulation of goods
High average price per prodcut

How can QbD Group help you enter the EU market?

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But complex to get started...

Highly regulated market
Differences in national interpretations or regulatory and GMP guidelines
Several EU directives to comply with
+30 different national languages

How can QbD Group help you enter the EU market?

Our end-to-end solutions

With deep industry knowledge and extensive experience, our team is equipped to handle all aspects of your journey into the European market.

Successfully entering the European market requires a strategic plan and deep regulatory expertise. At QbD Group, we provide comprehensive support to guide you through the complexities of compliance and market authorization.

Our experts leverage their knowledge to minimize risks, reduce time to market, and ensure a smooth entry.

How can QbD Group help you?

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Feasibility Assesment

Navigate your pathway to the European market with confidence. Our in-depth feasibility study provides a tailored quality and regulatory plan.

Ensure you have a clear roadmap to successfully launch your product.

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GMP Support

We provide robust QA oversight (API manufacturer audit, CAPA Plan, QP Declaration, EU-GMP Audit, Toxicology reports, etc.) ensuring your contract manufacturing processes meet GMP standards.

Benefit from expert QTA advice and adherence to EU GMP guidelines.

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Regulatory

Stay ahead of the curve with our strategic regulatory support. From strategy and scientific writing to MA submissions, we’ve got you covered.

Achieve compliance and maintain market access with post-approval management.

Warehouse

EU-import warehouse & sampling

From import and customs clearance to GMP-compliant warehousing, we ensure seamless handling of your products. Our expert logistics services guarantee efficient distribution while maintaining regulatory compliance. Additionally, our sampling solutions support quality control and market readiness, helping you meet industry standards with confidence.

Streamline your supply chain with our end-to-end logistics solutions.

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QC Analysis

Elevate your product quality with our GMP-licensed QC laboratory services. Our cutting-edge labs provide reliable and compliant testing for all products.

Gain peace of mind and confidence in your market positioning.

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QP Batch Release

Ensure a smooth path to market with our Qualified Person batch release services. We offer meticulous testing and batch release in full compliance with regulations.

Support your regulatory success in line with EMA Directive 2001/83/EC.

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MAH Holder

Simplify your EU market entry with our Marketing Authorization Holder services. We offer reliable legal entities to act as your formal MAH.

Ensure your product meets all regulatory requirements smoothly.

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Vigilance

Safeguard your product’s reputation with our pharmacovigilance services. Our QPPV experts ensure continuous safety monitoring and compliance.

Protect both your product and patients with comprehensive vigilance solutions.

Each story is different

At QbD we understand each story is different so we can support you with tailor made solutions.

We provide expert support to all types of companies involved in the importation, manufacturing, distribution, and development of pharmaceuticals for the European market.

Whether you want to bring medicines into Europe, manufacture under EU GMP regulations or ensuring compliance across the supply chain we have the expertise to guide you through every step.

Do you need help with your european market access? Any type of product and any type of need, we got you covered!

Don't hesitate to get in contact!

Acces pharma european market | QbD Group

Why QbD Group?

Supporting life science companies worldwide, from idea to patient.

Navigating the European market requires a partner skilled in regulatory compliance, market access, and product lifecycle management. At QbD Group, we empower life sciences companies with flexible, end-to-end solutions from idea to patient:

Cost Transparency: Clear, upfront cost estimates aid budgeting.
Expert Network: Access over 700 specialists in QC, QP certification, PV, and Regulatory Affairs for EU medicine importation.
GMP Certification: Our GMP-licensed status (MIA, GMP 1843H, 1843V, 1843IMP) covers both commercial and clinical products, removing the need for individual authorizations.
Efficiency & Compliance: Streamlined importation ensures EU regulatory compliance, letting you focus on core operations.
Single Point of Contact: Enjoy flexible planning with a dedicated project manager.
Proven Success: With over 4,500 projects and 1,200 satisfied clients, our full-service project management delivers reliable results.

Contact us to get your product to EU

Ready to accelerate your market entry into Europe?

Our team at QbD Group is here to help! Whether you have questions about regulatory requirements, need strategic guidance, or are ready to start your project, our experts are available to support you every step of the way.

Fill out the form below, and one of our specialists will get back to you shortly to discuss how we can tailor our solutions to your needs.

Client Cases: A successful market entry into Europe with QbD Group support

Supporting Market Access to Essential Medicines in Europe

QbD Group supported a leading Asian pharmaceutical manufacturer in navigating EU regulatory requirements to bring essential medicines to Europe, ensuring compliance and paving the way for market authorization.

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