Solución y Gestión Regulatoria Especializada is a 100% Mexican Company that understands the Sanitary Regulations of a country in continuous movement. Our personnel have been carefully trained to interpret the law in compliance with the highest legal criteria. We comprehend the needs of the Health products market and have specialist that will provide solutions in Health Regulations for companies whose interest is to enter the Latin American market.
Our commitment is to provide an integral consulting service that will help you reach your goals by being your regulatory ally, reviewing scrupulously the product characteristics, Heath Authority approvals and legal documents to create a specific regulatory strategy.
We also offer theoretical / practical workshops based on real examples, for all levels, and if required, with curricular certification.
In Mexico, we offer the following services:
Import / Export permits
Free Sale Certificates
Good Manufacturing Practices certificate
Advertising Authorization for mass media
Training in national bidding (Tenders) processes.
SOP in Mexican Official Standards.
We also offer solutions in preclinical research, clinical research, biocompatibility studies, stability studies; The preclinical lab is recognized internationally and authorized by the Mexican Ministry of Health (COFEPRIS).