Currently browsing "CRO"
-
CDMO and CRO Quality Agreements: Outsourced Oversight When the Client Owns the Product, Not the Process
A sponsor company signs a manufacturing agreement with a CDMO, ships over a validated process and a specification package, and moves on to the next milestone on the regulatory timeline. Eighteen months later, an FDA investigator asks the sponsor’s quality director a direct question: who approved this deviation, and why does your quality system show […]
-
CAPA for CROs: How to Fix Root Causes Before the FDA Finds Them
A CAPA process at a contract research organization holds up under inspection when it fixes the systemic condition behind a deviation. FDA investigators and sponsor auditors don’t ask whether a protocol deviation occurred — every active study has them. They ask whether the corrective action addressed why the deviation was possible in the first place, […]
