In 2017, we founded our QP Service and QP Certification business, Cilatus Manufacturing Services Ltd., as a separate entity in Dublin, Ireland in order to provide our clients with QP release services for commercial and investigational medicinal products. Cilatus Manufacturing Services Ltd. holds Manufacturing and Importation Licenses from the Irish Regulatory Authority (Health Products Regulatory Authority). The license numbers are M12235/00001 and IMP12234/00001. We are licensed to QP certify batches for the export of commercial and investigational medicinal products from the EU, to import into the EU for medicinal product for sale or use in EU clinical trials and for any medicinal products completely manufactured within the EU, we provide the QP certification necessary for their sale to the EU market or use in EU clinical trials.
For commercial and investigational products, we comply with all required EU legislation including GMP Guide Volume 4, Annexes 13 and 16, Clinical Trials Directive 2001/20/EC and others as required. We can fully support our clients by providing a comprehensive range of QP services including completing Supply Chain Maps, Auditing, QP Declarations, Dossier Review, and Product Quality Review activities.
Cilatus Manufacturing Services operates a validated electronic Quality Management System and a file-sharing platform ensuring full confidentiality, control, security and segregation for all client documentation. In addition, our validated documentation systems facilitate a streamlined and efficient transfer of documentation to and from our clients ensuring business continuity and integral back up as required.
EU GMP regulations require that Drug Product manufactured outside the EU must be imported to a EU site that has the appropriate license. Our Cilatus Manufacturing Services license enables us, if the client desires, to qualify, elect and contract with a logistics and warehousing company to facilitate importation of drug product into the European Union.
The team’s detailed knowledge of Good Distribution Practice requirements (EU Guideline 2013/C 343/01) ensures we can provide our clients with advice and guidance in relation to the most appropriate supply chain and distribution model. We can add the client’s products to our licenses, leading to efficiency and cost benefits for our clients. As described in Good Distribution Practice Guidelines our expert team can act as Responsible Person on behalf of our clients if required.