Cilatus has substantial experience and expertise in developing CMC development, CMC regulatory and manufacturing strategies that are fully integrated, smart and customized to the product development, regulatory, manufacturing and customer needs. Our strategies start at your current status of development or manufacturing and look forward three, five or ten years.
Cilatus has extensive CMC Development and CDMO Management experience and expertise. We have contracted, managed and overseen the CMC development from pre-clinical into late stage development at multiple CDMOs, contract manufactures and external laboratories for our clients. We have also successfully advised and supported the CMC development at customers who do CMC development internally.
Cilatus has broad and deep experience and expertise in clinical and commercial Manufacturing. We have managed tech transfers and overseen the manufacturing from pre-IND clinical, to late stage, to launch and to commercial manufacturing at multiple CMOs and contract manufactures. In addition, we have extensive manufacturing facilities development, design, construction, start-up and validation experience.