Corporate Director of Regulatory Affairs, R&D and Clinical Research, Biosidus
I have experience with registration of pharmaceutical, health care, vaccines, biologics/biosimilars and masive consumption products (including cosmetics , dietary supplements and probiotics) in Argentina (located- domestic market) and rest of the world ( international responsibility).
Imports and exports include mainly Latinamerican countries, USA and Europe but also countries in Africa, Asia and Middle East (as recent developing markets).
My personal goal is to achieve registrations all over the world following business expectations by accomplishing normatives and local legislations.
Regarding R&D dept, our goal focusing in biosinilars and Mabs registrations but also small molecules for cancer is to achieve good timelines together with a high standard dossier for worldwide registrations
In these processes a key point is the clinical area to perform clinical trials with excellent acceptance in a variety of countries but also the implementation of the requiered pharmacovigilance programs according to EMA and FDA standards.