Complete sanitary regulatory services for medical devices, drugs, cosmetic products, food supplements and more.
From registration, modification to extension, we cover all stages of the process, including technovigilance and pharmacovigilance.
Assembly Dossier to Medical Device or Medicine Homeopathic, Herbal, Vitamin, Allopathic (Generic or New Molecule)
New Record, Technical Modification, Administrative Modification, Renewal.
Start processCosmetic Products
Review of qualitative-quantitative formula, Post-market surveillance in marketing and advertising, Review of labeling according to standards applicable to the country of destination, Review of projects for import and export, Preparation of technical data sheets of cosmetic products, Product development, Information File (PIF) "Product Information File", Courses, Regulatory Advice, Review of compliance with NOM 259 Good Manufacturing Practices for Cosmetic Products.
Start processFood Supplements
Evaluation and Elaboration of Food Supplement Dossier, Evaluation of Label and Quali-Quantitative Formula, Formula Modification, Elaboration of Label in accordance with Appendix XVII of the RCSPS.
Start processTechnovigilance and Pharmacovigilance
Unit Registration, Preparation of SOPs for the units, Technovigilance Report, Periodic Safety Report for Pharmacovigilance, Development of Risk Management Plan for Pharmacovigilance or Business Unit for the Management and Performance of the Pharmacovigilance and Technovigilance units.
Start processAdvertisement Notice or Advertising Permit
Advertising for the health area, analysis of technological processes, elaboration of advertising and training material, search for scientific information that supports processes, medicines and medical devices, elaboration of reference guides for submission to COFEPRIS, visual aids and promotional guides.
Start process