Regulatory Affairs
Clinical Operations
Research Products Storage/Depot
Health records before COFEPRIS
Consulting Services
Complementary Services
Pharmacovigilance / Technovigilance
Business Solutions
Training
Health records before COFEPRIS
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.
Regulatory Affairs
Clinical Operations
Research Products Storage/Depot
Health records before COFEPRIS
Consulting Services
Complementary Services
Pharmacovigilance / Technovigilance
Business Solutions
Training
Health records for marketing
INFINITE has a highly specialized human capital to help our clients with obtaining their sanitary records necessary for the commercialization of their products within the Mexican territory.
INFINITE offers its services for registering medications and medical devices in Mexico, through specialized advice, armed with dossier zero defects, presentation and submission of information, as well as monitoring the registration process with regulatory authorities.
INFINITE has the experience and specialized personnel to be able to make health records of:
New Drugs
Medical devices
Medical equipment
Herbal medicines
Orphan drugs
Vitamin products
Food supplements
New formulas in food
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