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

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Regulatory Affairs

In the global framework of the pharmaceutical industry focused on biotechnology products development, norms vary on a permanent basis to achieve the highest quality standards. Thus, the area of Regulatory Affairs of Biosidus aims to be up-to-date with the knowledge of the norms. Furthermore, we try to anticipate and comprehend the ANMAT (National Authority of Medicine, Food and Technology in Argentina) regulatory policies, and those of the agencies in the more than fifty territories where our products are marketed.

The knowledge of the Regulatory Affairs is the technical and legal basis necessary for the governmental agencies that we interact with in order to register and commercialize our highest quality standards products in different territories.

In Biosidus, Regulatory Affairs is at the center of an ever more challenging and changing environment. Not only does this transform the medical and pharmaceutical paradigms that we know, but also makes us think of new ways of regulating, validating and focusing on the security and efficiency of our treatments, adhering to the national, regional (MERCOSUR) and international tendencies. This is a stage at which regulatory convergence and regulatory science are of paramount importance.

Among other activities, our approach involves: Health Establishments Authorizations , Registration of Pharmaceutical Dossiers, Registration of Brands, Export of Medications, First Batch Verification, Issuance of CLVs and Site Master Files, Approval of Medical Devices. Issuance of PBRERS, PSURS, International certifications, etc.