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.