QP Batch Certification

EU import and batch certification  of cell and gene therapies by Qualified Persons (QP)


Your reliable partner for fast and efficient QP certification

As a full service Contract Development and Manufacturing Organisation (CDMO), Minaris Regenerative Medicine offers EU import services and QP batch certification for cell and gene therapy products manufactured outside the European Union.

Our team of experienced Qualified Persons at our manufacturing facilities in Germany is ready to help you to enter the European market.


QP batch certification
  • Expert experience for any cell-based product
  • In-depth knowledge of European regulatory landscape
  • Flexible, client-oriented approach
  • Additional services such as release assays, storage, shipment handling, and consulting

    We offer this service to products manufactured at your facility or at Minaris USA. Minaris USA has EU GMP compliant clean rooms and certification can be provided by Qualified Persons at Minaris Germany for the EU market

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