Cilatus BioPharma Consulting 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. Over recent years, Cilatus BioPharma Consulting has developed deep expertise and continues to show sustained success in the selection, management, contracting and oversight of Contract Development and Manufacturing Organizations (CDMOs or CMOs) in the biotechnology space. We manage and oversee the development work, drug substance manufacturing, drug product manufacturing, analytical testing, labeling, shipping and supply management at contracted CDMOs and CMOs. On behalf of our clients, we have managed the entire CMC work performed at CDMOs for three new biologic molecular entities (NBE) from DNA generation to IND, Phase I/II, Phase III, BLA submission, Launch and into commercial Manufacturing. Cilatus BioPharma Consulting provides end to end leadership, strategy, consulting and operational management services for biopharma technical operations. The portfolio of services includes: CMC Development Strategy and Organisational Design, Operations Strategy and Organisational Design, Insource/Outsource Analysis, CDMO Selection & Management, Virtual CMC, Early & Late Stage CMC Development, Clinical Supply Strategy planning & management, Packaging & Labeling management, Late Stage Manufacturing Strategy, Manufacturing facilities Strategy, Conceptual Design & Cost estimations, Cost of Goods calculations, CMC Regulatory Affairs Strategy, support and operation, Quality System Strategy Design & Management.