QP Services

Your Partner for EU QP Services

Products having a marketing authorization or clinical trial materials have to be certified and released by a Qualified Person (QP). Delivery to customers / patients takes place only after our QP has released every lot produced and controlled in accordance with the relevant country’s legal requirements. Our service includes:

  • Advice relating to regulatory requirements
  • Consultancy services regarding GMP and GDP
  • Qualification of the supply chain, audit if necessary
  • Review of the manufacturing and testing records and check of compliance with EU GMP, IMPD and with the Product Specification File
  • Release decision
  • Certificate of Analysis, Certificate of Compliance with EU GMP, IMPD and with the Product Specification File
  • Archiving of retain samples and documentation in the EU

In addition, in case of EU-Import:

  • Definition of testing scope and release specifications for the EU
  • Incoming inspection of the received drug products, storage under quarantine until release decision
  • Sampling and batch re-analysis, if required

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