Acquired by PLG in June 2023
Cilatus BioPharma Consulting specializes in the management and leadership of CMC Development, GMP Manufacturing, CDMO/CMO Search and Management, Conceptual Engineering, Regulatory Affairs, Quality Assurance, and Qualified Person (QP) Release Services. Cilatus has contributed to the development and manufacturing of biopharmaceuticals of all product classes, small and large molecule products and ATMP - Drug Substances/APIs, Drug Products, Packaging and Labeling.
QP Certification Services
Cilatus Manufacturing Services Ltd., our dedicated entity based in Dublin, Ireland, offers licensed QP Certification and QP Release services for commercial and investigational medicinal products. Holding Manufacturing and Importation Licenses from the Irish Regulatory Authority (HPRA), we are authorized to provide QP certification and release services, and to ensure compliance with EU regulations, including Annexes 13 and 16. We operate a validated electronic Quality Management System and have expertise in Good Distribution Practice, we offer a wide range of QA services, from auditing to dossier review and product quality assessment. Learn more about our QP Certification and Release services and other QA capabilities on our website.
CMC Development and Manufacturing Consulting
Cilatus specializes in CMC development and GMP manufacturing consulting, offering tailored strategies and operational support for small/large molecule and ATMP products. Our expertise ensures integration and customization based on product development, regulatory, quality, manufacturing, and customer needs. We provide comprehensive solutions and integrated CMC strategies with a forward-looking approach spanning three, five, or ten years. Additionally, we excel in CDMO/CMO search and management, GMP manufacturing oversight, conceptual engineering, CMC/Reg. Affairs/Quality organizational design, and due diligence in the CMC area. For more information, visit our website.
Regulatory Affairs Consulting
Cilatus specializes in regulatory strategies and consulting, delivering tailored global regulatory pathways from discovery to post-approval activities. Our experienced Regulatory Affairs team analyzes your clinical development path, maps out regulatory milestones, addresses potential challenges, and ensures critical regulatory communications. We provide expertise in regulatory filings, agency interaction, CMC regulatory affairs, Quality by Design (QbD), and operational regulatory support. Whether it's authoring regulatory documents, assisting in agency meetings, or supporting license maintenance, we offer comprehensive solutions. For more information, visit our website.
Quality Assurance Consulting
Our Quality Assurance Consulting services encompass a range of expertise to support your quality operations. We can act as the Contract Head of Quality for start-up biopharma companies, we offer our in-depth knowledge of biotechnology and traditional pharmaceutical manufacturing processes to provide effective, phase-appropriate QA support. With our extensive auditing experience, we ensure compliance with global regulatory authority requirements such as the FDA, EU, and Japan, delivering comprehensive audit reports aligned with EU and US GMP guidelines. Our QA consulting team also assists with inspection readiness, pre-approval inspections, supplier qualification, and routine and for-cause GMP audits. Additionally, we specialize in the development of customized Quality Management Systems, including the review, improvement, and development of SOPs, forms, and Quality Policy manuals. Visit our website for more information on our Quality Assurance Consulting services.
