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 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.
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As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.