- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
- Aruna Asesores
- +57 315-6012347
- 4271544
- info@arunasesores.com
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*With our services, marketing authorizations are achieved in the countries where we operate, we provide regulatory services, we do not manufacture products
The firm provides advice and support in relation to the regime of sanitary registries and sanitary surveillance of in vitro diagnostic reagents for examinations of specimens of human origin regulated by Decree 3770 of 2004 and orphan in vitro diagnostic reagents, in vitro analytical grade, specific analyte, reagents for general use in the Laboratory and In Vitro Reagents in research used in samples of human origin regulated by Decree 1036 of 2018.
In the same way Resolution 000132 of 2005 that requires all importers to comply with a specific quality system for the storage of their products, our auditors offer in this case the possibility of preparing for the visit and subsequent obtaining of the Certificate of Conditions of Storage and Conditioning, necessary to obtain the Sanitary Registry.
Below, you will find the services associated with Diagnostic Reagents:
Check with our professionals online or get frequent questions about registration processes in different countries
Check with our professionals online or get frequent questions about registration processes in different countries
