Qualified Person Services (EU)


Each time a shipment of an investigational drug or pharmaceutical product is imported into the EU, a ‘Qualified Person (QP)’ is required to approve it. Marken’s QPs provide a full service including reviews of all manufacturing documents to verify that the manufacturer and drug product comply with EU GMP requirements before they can be distributed within the EU. Marken QPs can also be contracted to approve and release batches, at the client’s discretion.