Cilatus BioPharma Consulting
Cilatus BioPharma specializes in the management and services of CMC Development, CMC Regulatory Affairs, Quality Management, Engineering, Validation/Qualification and Manufacturing for biological products. Cilatus supports small, medium and large biopharma companies in strategy development, strategy execution and operations with our fully integrated team of experienced consultants.
Cilatus Regulatory Services
Cilatus Regulatory Services is a highly experienced Regulatory Consultancy based in Dublin, Ireland. We have extensive EMA, EU, FDA & global regulatory expertise with broad expertise in CMC for biologics, small molecules and veterinary products.
Cilatus Manufacturing Services
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.