- We provide consulting services to define the most efficient regulatory strategy to obtain product registrations, modifications, medicine cession rights, and other health supplies and devices, such as: Class I, II, or III.
- We provide advice-support for the classification of medical devices and equipment for the registration by COFEPRIS.
- We provide the figure of Legal Representation for the registration of medicines and other health supplies and equipment for companies without an established presence in Mexico.
- Integration and preparation of medicine dossiers, medical devices and equipment, food supplements, food, beverages, and other products for human use and consumption.
- Preparation and authorization of product advertising projects by COFEPRIS.
- Product labeling for human use and consumption.
- Development and monitoring of preclinical and clinical research protocols, as well as bioequivalence and bioavailability studies.
- Submission and approval of Good Manufacturing Practices (GMP) and health licenses.
- Support in pharmacovigilance, techno vigilance, and quality management systems.
- Value arguments integration for the New Molecules Committee.
- Approval for health authorizations such as import and export permits.
- Support for pharmacies operation.
