Licensed QP 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). We comply with all required EU legislation including GMP Guide Volume 4 Annexes 13 and 16 and Clinical Trial Directive 2001/20/EC.
Cilatus Manufacturing Services has broad and deep experience in the area of auditing and can partner with our clients to provide a comprehensive and high quality auditing services to ensure compliance with all aspects of EU and US GMP guidelines including Annex 16 for auditing API, Drug Product, Packaging and laboratory facilities.
Importation / Warehousing
The Cilatus Manufacturing Services licence 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. As per the Good Distribution Practice Guidelines our expert team can act as Responsible Person on behalf of our clients.