CMC Development and Manufacturing Consulting

CMC Development and Manufacturing Strategies

Cilatus has substantial experience and expertise in developing CMC development and manufacturing strategies for small/large molecule and ATMP products that are fully integrated, smart and customized to the product development, regulatory, manufacturing and customer needs. Our strategies start with the current status of development or manufacturing and look forward three, five or ten years.

CDMO/CMO Search and Management

We have developed and refined our own Cilatus CDMO/CMO search and selection process and performed more than 20 CDMO/CMO searches to date. We have led contract negotiation for clients with CDMO/CMOs, managed and overseen the CMC development and GMP manufacturing from pre-clinical into late-stage development for small/large molecules and ATMP products at multiple CDMOs/CMOs and external laboratories for our clients.

GMP Manufacturing

Cilatus has broad and deep experience and expertise in clinical and commercial GMP Manufacturing. We have managed tech transfers and overseen the manufacturing from pre-IND clinical, to late stage, launch, and commercial manufacturing at multiple CDMOs and contract manufactures.

Conceptual Engineering and GMP Manufacturing Facilities

Based on our extensive Engineering experiences, we have helped our clients to develop well-defined scopes, realistic budgets, and timelines for their facility project. We can perform conceptual engineering services and then program manage and lead the selection, contracting and management of engineering, construction, and validation companies. We have performed due diligence services for purchase or lease of manufacturing sites and facilities for clients.

Organizational Design and Development

For clients with in-house CMC development, GMP Manufacturing, Regulatory Affairs, and QC/QA departments, we have analyzed and benchmarked the size, management, and leadership for multiple clients. We have proposed revised organizational models and implemented organizational change for more efficiency, improved organizational health and clarity. We have guided and coached individuals, departments, and organizations successfully through organizational change.

Due Diligence

We have performed multiple due diligence projects in CMC development, GMP Manufacturing, Reg. Affairs, and QC/QA area for Investment, Private Equity, and Biopharmaceutical companies.