EU Product Release
Under EU legislation, all products manufactured outside the EU or states without mutual recognition, must have release testing performed upon import into the European market. This testing, combined with appropriate assessments of the related quality systems by a European Qualified Person (QP), enables products to be released to market.
Eurofins combines testing and auditing expertise to offer a full service package: from audits of production sites to QP release in the EU, including imports, storage, and analysis of your products in strict compliance with cGMP.
We have been supporting our clients global supply chains and entry into the EU for over 20 years from our facilities in the European Union.
European Product Release Services
Comprehensive Biologic and Pharmaceutical Product Support
- Audits of sterile & non-sterile medicinal products & API/raw materials manufacturers
- Support to create or improve Quality Assurance systems
- Imports
- Product Receipt and Storage
- Method transfer/ validation
- Physico-chemical analysis
- Microbiological analysis
Why Choose Eurofins BioPharma Product for Testing?
Eurofins BioPharma Product Testing state-of-the-art global facilities offer extensive laboratory capacity and the highest level of instrument technology, enabling our facilities to become an extension of your own operation.
Our flexible operating systems allow timely testing and reporting of your results to expedite market entry. One of our dedicated client service representatives will monitor and report progress on your release.
Our 25-year history of cGMP compliance ensures you will receive the highest quality data. We meet your global reporting needs with data that is generated in full compliance with the European Medicines Agency.
We work extensively with many of the world’s leading global biopharma companies in this area and have established relationships with logistics organisations, importers and QPs.
Why choose Eurofins Healthcare Assurance for auditing?
Eurofins, through the Healthcare Assurance business line, offers GMP audits to ensure compliance with internationally recognised standards and market requirements. Our auditing process is impartial and fully independent from testing.
Our auditors and consultants are experts coming from the pharmaceutical industry with a high level of qualification and a recognised experience. We audit sterile and non-sterile medicinal products, excipients, packaging and API manufacturers, as well as the connected service providers.
Eurofins Healthcare Assurance’ network is made of internal specialists and external qualified partners and is covering all strategic international locations where healthcare manufacturers, their supply chains and distribution flows are located.
