CMC health check

OBJECTIVE:

“I am nearing a critical milestone in my clinical development plan (e.g. preparing for GMP manufacture, or heading towards Phase 3 supply) and need to know if my manufacturing processes and analytical methods are fit for purpose.”

 

SCOPE FOR CEREBRO CMC:

> Review the current processes intended or applied for manufacture of drug substance and/or product

> Review the analytical methods used to support manufacture and release

> Review the current stability data and assess the suitability of the drug substance and drug product formulations, and storage conditions

> Check that key GMP prerequisites and best scientific principles are adopted

> Identify the key CMC issues and gaps that may impede successful regulatory filing

> Report findings with advice on necessary or recommended remediation

 

TIMELINE:

A CMC Health Check package typically spans a period of 1 month, inclusive of time for the client to find any requested documentation.