CMC requirements
in Latin America

Global Manager of CMC Regulatory Affairs Estefanny K. Da Silva N. is a Pharmacist by training. She has 10 years of local, regional and global experience in Regulatory Affairs working for multinational companies with pharmaceuticals, biotechnological products and medical devices.

Regulatory Affairs Consultant Ana Terra dos Santos Macedo has more than 13 years of experience in Regulatory Affairs, involving regulatory cycle of products, since the evaluation of the feasibility of new products, marketing application strategy, certification of good manufacturing practices, to the maintenance of the products through the critical evaluation, classification and proper submission of variations in accordance with the current regulations. Currently Ana Terra is responsible of Marketing Authorisation submissions and maintenance of wide portfolio of products in the International division (LATAM Region).

Associate at Regulatory Affairs Julieta Breton has 10 years of experience in the pharmaceutical industry, involving in activities related to quality control, R&D, pharmacovigilance and regulatory affairs. She has strong experience in preparation of marketing authorization applications for medicinal products, and activities related with the pharmaceutical industry as new sites of authorization and product variations. Currently Julieta is responsible of MA submissions and maintenance of wide portfolio of products in the International division (LATAM and Central American Region).