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Category Archives: change orders

APIs, Quality Agreements and the Partner-or-Supplier Debate.

It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.  The consensus seems to be that the FDA shifted the responsibility…

Posted in agreement, APIs, change orders, Contract Manufacturing, CRO/CMO, FDA, ICH, method development, Project Management, Quality Agreement | Comments Off on APIs, Quality Agreements and the Partner-or-Supplier Debate.