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Monthly Archives: January 2014

API Regulatory Challenges: 5 Things You Need to Avoid

Posted on January 10, 2014 by

At the heart of every drug lies one or more active pharmaceutical ingredients (APIs). While the phrase “regulatory affairs” typically conjures thoughts of FDA approvals of finished-dose drugs, regulatory matters…

Posted in APIs, Contract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on API Regulatory Challenges: 5 Things You Need to Avoid