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Category Archives: regulatory

Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

Posted on April 1, 2013 by

For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a…

Posted in CEP, Congtract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off on Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

Looking for an API Supplier? 5 Things to Consider

Posted on March 6, 2013 by

Outsourcing production of APIs provides pharmaceutical and biotech companies the benefit of API scale-up and production expertise while allowing them to focus on their core business – the research and…

Posted in APIs, Contract Manufacturing, CRO/CMO, QA/QC, regulatory | Comments Off on Looking for an API Supplier? 5 Things to Consider