Dossier Preparation: Sanitary Registration of Medical Devices and Pharmaceuticals

Dossier preparation (drugs, medical devices, obtaining alpha-numeric key for herbal remedies, recognition of orphan drugs), as well as equivalence procedures.

This service consists of the request and evaluation of the legal and technical information required to obtain the sanitary registration of the input that is the reason for the request, as well as the information for modifications or extensions of sanitary registrations. Advice during the conformation period to support the client in the generation or request of the required information, as well as to establish regulatory strategies. Additionally, we carry out the elaboration of labels, registration project, application form, clarification letters and all the information required to be presented in the dossier. We print all the information to be included in the dossier and prepare the dossier based on the requirements of the administrative-legal and technical modules. We support in the processing of apostilles before the Mexican authority and in the request of certified copies.