At Clinigen, we have a genuine interest in the well being of others, providing clients with the highest level of standards, ethics, and quality.
We demonstrate our commitment to quality by consistently requiring stringent QA oversight, differentiating our Clinical Supplies Management team from any other clinical supply management company, through our Qualified Person (QP) services.
One of the advantages of working with us is access to our two established sites in the post-Brexit EU. Our in-house QPs can support both EU and UK drug product release and batch certification, mitigating any Brexit-related risk for your clinical trial. Your QP is responsible for ensuring that the clinical product your study calls for has been manufactured and/or imported in accordance with EU GMP or equivalent satisfactions.
The Clinigen process focuses on providing the best Qualified Person Services for your clinical trial supply needs.
A Qualified Person (QP) is primarily responsible for ensuring that the clinical product your study calls for has been manufactured and/or imported in accordance with EU GMP or equivalent satisfactions.
It is due to EU regulations that the manufacture of medicinal products, or importation from a third country, is subject to holding a Manufacturing and Importation Authorization.
The national competent authority of the Member State in which the manufacturer or importer operates, issues these authorisations and the Clinigen process focuses on upholding these standards while providing the best Qualified Person services for your clinical trial supplies.
This ultimately shortens timelines and reduces costs while improving overall quality.
It is important to note that all Qualified Persons and QP backup personnel are additionally available at Clinigen’s EU sites.
For more information regarding Clinigen’s exceptional QP service capabilities, read this Case Study to learn more about how we helped a Contract Manufacturing Organization (CMO) take an investigational medicinal product (IMP) into Europe.
Vice President of Technical Operations, BioPharma Company
As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 50% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.