Qualified Person Services (EU)

Each time a shipment of an investigational drug or pharmaceutical product is imported into the European Union, a Qualified Person (QP) is required to approve it. The QP is a highly specialized and rigorously qualified role that oversees batch certification and release.

Marken’s team of QPs provides a full service including:

  • Processes and procedures established in accordance with the EU Clinical Trial Directive 2001/20/EC
  • Audits and reviews of all batch records and test results against the IMPD and the Clinical Trial Application Form
  • Provision of Certificates of Release to allow drugs to be distributed within the EU
  • Capability to contract to approve and release batches at the client’s discretion

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