Cilatus BioPharma Consulting was founded in 2014 and is headquartered in Dublin, Ireland with offices in Sarnen, Canton Obwalden, Central Switzerland.
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, we have developed deep expertise and continue 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.