CERTIFICATIONS
Quality management and care for the environment
ARN
Organismo dedicado a la regulación y fiscalización de la actividad nuclear en las áreas de seguridad radiológica y nuclear, protección y seguridad física, y salvaguardias y no proliferación.
IQNET ISO 9001:2015
Certificate of Quality Management System whose scope is design, development, manufacture and marketing of medicinal specialties, short half-life cyclotron products and medical technology products.
ANMAT
Medical products – IN VITRO diagnostic products. Manufacturers, Exporter and Importer of Medications for diagnosis – Radiopharmaceuticals – Radionuclide generators – 131I Capsules
DIGEMID
Good manufacturing practices for pharmaceutical products: Non-sterile solid radiopharmaceuticals, radionuclide generator, medicines and radiopharmaceuticals in the sterile area.
ANVISA
Good Manufacturing Practices for Class IV Medical Products and Health products (Medications: sterile products, small-volume parenteral solutions with final sterilization, capsules and non-sterile liquids).
OPDS
Certificate of environmental suitability.
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