INFINITE has great experience in the process of processing for health records before the Mexican authority COFEPRIS, we support you from the beginning of the classification and administration of the information necessary to register your medications, food supplements, herbal products and medical devices. We take you by the hand throughout the process from the initial submission of information to the final COFEPRIS opinion.
In addition, INFINITE has the ability to develop the dossier to submit the registration of a product to a basic table, as well as the processes necessary to monitor and lobby for obtaining the registration in the sector.
For the commercialization and registration of new medical products or medical devices we offer the integral development of the following services:
Arming dossier for medication registration
Arming dossier to register medical devices
Armed dossier for registration of herbal medicines
Armed dossier for registration of vitamin products
Arming dossier for orphan drug registration
Submission of advertising
Review of legal texts
Obtaining technical appointments with the committee of new molecules
Review of requirements for reference laboratories
Review of information against Mexican regulations
Simple and certified translations
Follow-up to the entire process until COFEPRIS resolution