Pharmaceutical and Biotechnological Products
In Chile, according to local regulations, all pharmaceutical products imported or manufactured in the country must have the authorization of their sanitary license issued by the Public Health Institute (ISP) prior to their distribution.
The sanitary license consists of a product evaluation process and systematic study of its pharmaceutical, pharmacological, toxicological and clinical properties, aimed at verifying its quality, safety and efficacy.
Sanitary requirements, evaluation complexity and timelines involved in obtaining a sanitary license vary depending on the type and nature of the product.
At DC & Blue we have professionals with extensive experience in the regulatory field for the submission, obtaining and maintenance of sanitary licenses for pharmaceutical and biotechnological products.
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