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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