Gaining entry to the European pharmaceutical market demands full compliance with EMA regulations. For manufacturers based outside the EU, or those not covered under Mutual Recognition Agreements (MRA), this presents a complex regulatory challenge. No batch can be released in the EU without a certified evaluation by a Qualified Person (QP). This is a requirement that applies to finished medicinal products and IMPs (Investigational Medicinal Products) alike.

With GMP-compliant facilities located within the EU, the Eurofins BPT network of laboratories offers a comprehensive EU product release solution, including support for the importation process, method transfer, batch/lot release testing, QP certification, and regulatory assistance.

Our experienced QPs perform detailed reviews of your product’s analytical and manufacturing data, assess the related quality documentation and systems and issue the required Certificate of Analysis (CoA) to ensure legal release into the EU market.

The end-to-end EU product release services Eurofins BPT provides include:

• Customs clearance, warehousing, and import authorisation support
• Analytical method transfer and validation
• GMP batch and lot release testing
• Documentation review by qualified persons (QPs)
• Issuance of CoAs and QP release certification
• Investigation of Out of Specification (OOS) results
• Audits of manufacturing sites outside the EU 

Whether you’re launching a new product or managing a global distribution network, our integrated services ensure your product reaches the EU market without costly delays. Our QPs work closely with our testing teams to maintain the highest regulatory standards while remaining responsive and pragmatic, minimising turnaround times and maximising reliability.

In the event of a deviation or OOS result, Eurofins BPT provides rapid investigation, backed by expert technical teams to support mitigation strategies and restore release timelines. Our global network can also audit your manufacturing sites outside the EU, ensuring your operations align with EMA expectations and GMP standards.

From import logistics to QP certification, Eurofins BPT provides the operational stability and regulatory expertise needed to unlock the EU market for your pharmaceutical and biopharmaceutical products.