CDMO and CRO Quality Agreements: Outsourced Oversight When the Client Owns the Product, Not the Process
9 min read
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 […]
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