Regulatory consultancy specialized for national and international laboratories

We operate with technical independence, absolute confidentiality, and health responsibility, positioning ourselves as a Trusted Regulatory Partner for organizations seeking excellence, institutional security, and a long-term vision.

Our services

Registry of medicines

We manage the process for obtaining the Sanitary Registration of Generic, Herbal, Vitamin, Biological and Biotechnological Medicines, integrating the dossier and comprehensively coordinating the regulatory strategy for their authorization and commercialization

Food supplements

We manage the classification consultation for dietary supplements and provide comprehensive advice on label preparation and review, ensuring compliance with current COFEPRIS regulations, guidelines, and criteria, guaranteeing regulatory compliance for their proper marketing in Mexico

Medical devices

We manage the process for obtaining the Sanitary Registration of Class I, Class II and Class III Medical Devices, coordinating the regulatory strategy and the integration of the technical file to guarantee compliance with the applicable regulatory requirements

Import

We comprehensively manage the import procedures for regulated products, from obtaining the Import Health Permit to coordinating the customs release process, ensuring compliance with health and customs regulations

Trademark Registration

We manage trademark registration with the IMPI, incorporating feasibility analysis, name availability studies, and strategic management of the entire process until its resolution

Incorporation of companies

We structure and manage the incorporation of companies in Mexico, with a specialized focus and comprehensively coordinating the legal, corporate and regulatory aspects

Additional services

Storage and distribution warehouses

We offer a comprehensive service for warehouses and distribution centers, focused on the implementation and strengthening of the Quality Management System, including the development of the Quality Manual, Standard Operating Procedures, and all the necessary documentation for compliance with Good Distribution Practices (GDPs)

Pharmacies

We provide a comprehensive service for pharmacies, including the development of procedures, controls and documentation necessary for compliance with applicable health regulations and good storage and dispensing practices