Remove 2022 Remove Article Remove Compounding Remove Method Validation
article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

This article offers an overview of the CMC requirements for the small molecules product registration process in Latin America. Decree 334/2022. “By Firmino 1 May 2023 The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements.