LICENSED QUALIFIED PERSON RELEASE
Cilatus Manufacturing Services core business is to provide End-to-End QA review and QP release services for commercial and investigational medicinal products. We are licensed by the Irish Regulatory Authority (Health Products Regulatory Authority) 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.
Our Quality Assurance Team has in-depth knowledge of biotechnology and traditional pharmaceutical manufacturing processes.
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 QA services including completing Supply Chain Maps, QP Declarations, Dossier Review and Product Quality Review activities.
We operate 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.