Our processes are conducted in accordance with strict International Standards (AAMI, ISO, GMP, etc.) that guarantee the highest levels of quality in each stage. We are the first company of this type in Latin America with a Quality Management System adapted and certified by AEMPS under ISO Standard 13485, that has ENAC certification and that uses processes adapted to ISO Standards 11135 and 17665-1. Furthermore, we have ISO 9001 certification, issued by DNV GL (**), and we are authorized by Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT) and the Buenos Aires Province Ministry of Public Health.
(*) We are able to provide sterilization services for industries that are conducted in accordance with Standard UNE-EN- ISO-11135 (Notified Body No. 318 - Spanish Agency of Medicinal Products and Medical Devices)
(**)We are able to provide sterilization services using steam, ethylene oxide and hydrogen peroxide plasma. Material is prepared, fractionated and conditioned using the aseptic technique.