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Optimizing Pharmacovigilance for a Biotechnology Leader
QbD Group improved the pharmacovigilance for a global leader in biotechnology who wanted to access the Iberian market, ensuring regulatory compliance and patient safety.
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.
Thanks to our end-to-end solutions, you can confidently manage the complexities of the market and ensure your products reach patients efficiently.
Why enter the EU market?
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
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
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.
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.
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.
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.
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.
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.
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!
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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
Get the latest industry news
Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve.
