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