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About Cilatus Manufacturing Services

Cilatus Manufacturing Services Ltd was founded in 2017. It is headquartered in Dublin, Ireland.

Cilatus Manufacturing Services specialises in providing End-to-End Quality Assurance review and Qualified Person Release services for commercial and investigational medicinal products as required by regulations including the Clinical Trial Directive 2001/20/EC, EU GMP Guide Volume 4 Annex 13 and Annex 16 from Drug Substance through to Drug Product and Packaged Lots.

Cilatus Manufacturing Services hold Manufacturing and Importation Licences from the Irish Regulatory Authority (Health Products Regulatory Authority). The Licence numbers are M12235/00001 and IMP12234/00001.

Our integrated team of Quality Professionals has a broad range of QA and compliance experience ranging from Drug Substance /API Manufacturing, to Formulation and Drug Product manufacturing and all Quality Aspects of Packaging, Storage, and Distribution.

Our team has impressive professional experience in Pharmaceutical and Biopharmaceutical companies, deeply understands small and large molecule manufacturing quality requirements and has been exposed to in-house and outsourced/ CMO manufacturing of pharmaceutical/biopharmaceutical products in almost any part of the world. Our team has performed many audits, has hosted FDA/EU inspections, contributed to quality remediation projects and implemented full quality systems.