European regulations require that a Qualified Person (QP) certify that every investigational medicinal product (IMP) entering the EU has been manufactured in accordance with all applicable laws and regulations. For a recent clinical trial, Clinigen Clinical Supplies Management helped the sponsor’s contract manufacturing organisation (CMO), located in China, import a biological product for use in a clinical trial in the EU.
Read the case study to discover how our network of qualified auditors enabled us to provide the sponsor with the QP declaration needed for the IMP to be certified on time and ensure the clinical trial could be carried out in full compliance with European and local regulations.
