article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. In addition, a method transfer protocol and report also need to be generated and included in the dossier, as appropriate.