Cilatus Manufacturing Services Ltd

Based within the EU (Dublin, Ireland), Cilatus Manufacturing Services Limited (CMS) holds two Manufacturing & Importer's Licences (MIA) to provide Qualified Person Batch Release of commercial and investigational medicinal products. In that service, we undertake End-to-End Quality Assurance review of each batch either to import into the EU or to export from the EU. We also oversee distribution activities and can act as your Responsible Person (RP). Underpinned by deep expertise of biological products and small molecules, we work with complex supply chains, to make sure that your product meets all requirements for the territory of your interest. On your behalf, we undertake the QP certification of your batches as required to export from the EU or to import into the EU. As well as certifying your batches, we also offer a range of related QA services. We have strength in supply chain management and oversight, remediation of complex quality and compliance issues, QP compliance auditing, and due diligence activities, and we will tailor your quality management system. Our sister company, Cilatus BioPharma Consulting supports us with a fully integrated team of technical SME's as required to enable us to support small, medium and large sized biopharma companies.