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Monthly Archives: May 2015

No Straight Line: Confronting API Scale-Up Challenges

In many of the blog posts we’ve written over the last few years, we’ve referenced the growing complexity of active pharmaceutical ingredients (APIs). It isn’t just mindless chatter intended to…

Posted in CMC, Contract Manufacturing, CRO/CMO, R&D, Route Design, scale-up | Comments Off on No Straight Line: Confronting API Scale-Up Challenges

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It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management.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.