Investigational Medicinal Product Management
The importation and distribution to clinical sites of an IMP manufactured outside the European Union presents a significant logistical challenge. It is a legal requirement that an IMP manufactured outside Europe be released into Europe by a European Qualified Person (QP) before it’s distributed to the relevant clinical sites. Kinesis Pharma provides services to facilitate and manage IMPs for clinical trials in the EU e.g. arranging for QP release and managing the sponsor’s relationship with the QP, label and packaging (patient kits) and shipment to clinical sites.