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This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. You may unsubscribe from these ISPE communications at any time. And beyond that, they should willingly improve regulatory frameworks to streamline processes and global harmonized requirements (e.g.,
This article will examine the current global regulatory submission workflow for postapproval CMC changes and will propose principles to streamline regulatory submission authoring through the utilization of ICH Q12 concepts, in combination with SCDM. US Food and Drug Administration. Center for Biologics Evaluation and Research.
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