° Review, adaptation and conformation of the dossiers of generic, herbal, vitamin, new molecular entity, biological, biotechnology drugs and blood products, as well as medical devices Class IA, I, II and III, of foreign manufacture for obtaining the marketing authorization by COFEPRIS.
° Review and conformation of the dossiers of generic, herbal, vitamin, new molecular entity, biological, biotechnology drugs and blood products, as well as medical devices Class IA, I, II and III, of domestic manufacture for obtaining the marketing authorization before COFEPRIS.
° Pre-review of dossier for modification, renewal or obtaining the marketing authorization of the generic drugs, new molecular entity, biological, blood products and biotechnology, as well as medical devices Class IA, I, II and III both domestic and foreign manufacturing.
° Preparation of the dossier for requesting an appointment to the Committee of New Molecules (including biotechnology) and support for the preparation of the corresponding presentation.
° Review, adaptation and conformation of dossiers for obtaining the Marketing Authorization of medicines in other countries (Latin America, Europe, United States and Canada).
° Technical-regulatory support “IN-PLANT” in everything related to Regulatory Affairs.
° Classification of food supplements.
° Answer of deficiency letters.
° Organization of the dossier according to the checklist or CTD format.
° Preparation of file for request for verification visit abroad.
