Regulatory Affairs


Our consultancy specialized on technical and legal procedures for healthcare industry includes advising and performing all kinds of tasks related to medical devices in general, such as:

Obtaining authorization for installation and operating pharmacies, pharmaceutical store, drugstore, warehouses, production laboratory and quality control laboratory established in Chile.

Advise on the rules and regulations of labeling and instructions of use for sanitary products.

Preparation and, or revision of technical Dossiers/technical files, and any of its parts.

Legalization of foreign documents.

Preparing contracts with distributors of sanitary products and quality control laboratories, necessary for obtaining records with the health authority.

Carrying out the necessary procedures for the registration of medical devices in Chile, as well as its maintenance and update according to current regulations.

Perform the steps required to market all types of sanitary products.

Health authorization of advertising for health products aimed at the public media (television, radio, newspapers, magazines and internet).

We offer technical consulting from a specialized Pharmaceutical Chemist responsible for the technical information submitted to the Public Health Institute of Chile, according to the provisions of Presidential Decree No. 3 of 2010 and to carry out any procedure using GICONA system.

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