Pharmacovigilance is a set of procedures and activities aimed to detect, assess, register and prevent adverse reactions as well as any other problems relating to medications.

Biosidus welcomes your inquiry – submit the form below:

Regulatory Affairs

Within the framework of the global biopharmaceutical industry, focusing on product development, regulatory requirements vary across different product types, regulatory authorities, and where the product is in its lifecycle. Our Regulatory Affairs & Pharmacovigilance department keeps Biosidus up to date on these standards. In Argentina, we try to anticipate ANMAT (National Authority of Medicine, Food & Technology) regulatory changes, as well as those in more than 50 other territories where our products are marketed.

Our team retains the technical and legal knowledge necessary to meet the requirements of all relevant national health agencies that we interact with. We also maintain the relationships that enable us to register and commercialize our high-quality products in key territories worldwide.

At Biosidus, Regulatory Affairs is at the center of a challenging and continually changing environment. Not only does this transform the medical and pharmaceutical paradigms we know, but also forces us to think of new ways of regulating, validating and focusing on the security and efficiency of our products, adhering to regional (MERCOSUR), national and international requirements. At this stage, regulatory convergence and regulatory science are of paramount importance.

Among other activities, our work involves health establishment authorizations, registration of pharmaceutical dossiers, registration of brands, export of medications, first batch verification, issue of CLVs and site master files, approval of medical devices, issue of PBRERS, PSURS, and international certifications, etc.