1. Notice of Operation (Aviso de Funcionamiento)
We advise and manage the filing of the Notice of Operation, a mandatory procedure for establishments that handle products or provide services representing a health risk. This process consists of notifying COFEPRIS of the existence of the establishment, its location, and the activities it performs, ensuring the lawful commencement of operations in accordance with applicable regulations.
2. Amendment of Notice of Operation
We provide support in updating and amending the Notice of Operation in the event of changes to the address, health responsible officer, activities, processes, or any information previously reported to the authority, ensuring continuous regulatory compliance.
3. Obtaining Health Registrations
We provide comprehensive advisory and management services for obtaining health registrations before COFEPRIS for products subject to prior authorization, such as medicines, medical devices, pesticides, plant nutrients, and other regulated products. Our support includes regulatory feasibility analysis, preparation of the technical-legal dossier, response to official requests or deficiencies, and continuous follow-up until resolution.
4. Prior Sanitary Import Permits (PSPI)
We advise and manage the process before COFEPRIS to obtain Prior Sanitary Import Permits, required for the lawful entry of regulated products into national territory. Our support aims to prevent delays, rejections, or contingencies at customs by ensuring full compliance with technical and documentary requirements.
5. Labeling Review
We review and validate that product labeling complies with applicable health regulations, including product name, ingredients, mandatory legends, and warnings, in order to prevent sanctions, product seizures, and to ensure clear and transparent communication to consumers.
6. Product Classification Consultation before the Ministy of Health
We manage classification consultations so that the authority issues a technical opinion regarding the legal nature of a product, based on its formulation, presentation, and labeling, determining whether it is subject to specific health regulation.
7. Nutritional Facts Panel
We prepare and verify the Nutritional Facts Panel in accordance with current Mexican regulations, ensuring that nutritional information is accurately expressed, verifiable, and aligned with technical criteria required by the health authority.
8. Advertising Permit
We manage advertising authorizations before COFEPRIS, ensuring that product promotion is lawful, ethical, and effective through truthful, substantiated messaging aligned with applicable health regulations.
9. Regulatory Submissions and Filings
We draft and submit legal and technical documents before the health authority to address official requests, clarifications, information requirements, follow-ups, and other necessary regulatory procedures.
10. Certificates of Free Sale for Export
We advise and manage the issuance of Certificates of Free Sale, essential documents for product exportation, certifying that products are legally commercialized in Mexico and comply with applicable health regulations.
11. Regulatory Back Office
We provide ongoing regulatory back-office services, offering continuous support in the management, monitoring, and control of regulatory procedures, obligations, and strategies, allowing our clients to focus on their core operations.
12. Regulatory Due Diligence
We conduct regulatory compliance audits and assessments, identifying risks, contingencies, and areas for improvement in health matters, with the objective of strengthening decision-making, preventing sanctions, and ensuring lawful operations.