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Strategic Regulatory Partner for Success in Mexico
Greetings from
Pharma Wizard Mexico Regulatory Services
Pharma Wizard is one of the largest global Regulatory-focused solutions and services companies. We support Life Sciences organizations in entering the Mexican pharmaceutical market by assisting across the entire Regulatory value chaināfrom strategy and market intelligence to local representation and post-approval product maintenance.
In Mexico, the Federal Commission for the Protection against Sanitary Risk (ComisiĆ³n Federal para la ProtecciĆ³n contra Riesgos Sanitarios), commonly known as COFEPRIS, is the national health authority responsible for the registration of pharmaceutical products, medical devices, cosmetics, and food supplements.
With an experienced on-ground team of local Regulatory experts, Pharma Wizard provides full support in obtaining COFEPRIS approvals, ensuring smooth and compliant market entry into Mexico.
Industries We Serve
- Medicinal Products
- Medical Devices
- Food and Food Supplements
- Cosmetics
The āComisiĆ³n Federal para la ProtecciĆ³n Contra Riesgos Sanitariosā (COFEPRIS) is the key Drug Regulatory Authority in Mexico. Drug department of the COFEPRIS is responsible for handling and licensing of the manufacture, import, export, distribution, promotion, advertising, and pharmaceutical product registration. COFEPRIS is also responsible for assessing the safety, efficacy, and quality of medicinal products, issuing marketing authorizations, and for monitoring the quality & safety of marketed medicinal products.
- End to end Registration Support
- Authorized Local Agent Support
- Regulatory Affairs Consulting
- Strategic Regulatory Guidance During Product Development
- Gap Analysis, Review, Compilation & Submission of the Dossier to COFEPRIS
- Interacting with COFEPRISA
Mexico is the import hub for Medical Devices in Latin America. Mexico Medical Device Registration is regulated by the Federal Commission for the Protection against Sanitary Risk (ComisiĆ³n Federal para la ProtecciĆ³n contra Riesgos Sanitarios, COFEPRIS). Foreign manufacturers must appoint a Mexico Registration Holder (MRH) for registering their device.
- Diagnostic Agents
- Medical Equipment (I.E. Accessories And Appliances)
- Prosthetics, Orthotics, And Functional Aids
- Surgical Materials
- Hygiene Devices
- Dental Supplies
The Mexican nutraceutical and dietary supplement markets are rapidly growing due to the rising health concerns, changing lifestyles of consumers, and increasing awareness regarding the consumption of healthy foods. The demand for fortified meals and beverages, such as calcium-enriched food and drinks, vitamins and nutritional supplements and high-fibre, low fat, sugar, cholesterol, and sodium products have traced an increasing growth over the years. The Federal Commission for the Protection against Sanitary Risk, formally known as COFEPRIS, is the apex Regulatory body in charge of food regulation in Mexico.
- Food Product Classification
- Formula Review/Ingredients Assessment
- Food Label and Claims Review
- Compliance as per New Labeling Regulation
- Claims Consultation and Substantiation
- Interacting with COFEPRIS
The Mexican cosmetics market is amongst the top revenue grossers across the globe. With a growing demand for cosmetic products among the countryās youth, the Mexican market projection suggests a rise in demand for cosmetic products.
There is no need for cosmetic registration or cosmetic notification with the Federal Commission for Protection against Sanitary Risks (COFEPRIS) before the commercialization of cosmetics in Mexico. Nevertheless, it is necessary to ensure adherence to the Regulatory compliance requirements.
There is no need for cosmetic registration or cosmetic notification with the Federal Commission for Protection against Sanitary Risks (COFEPRIS) before the commercialization of cosmetics in Mexico. Nevertheless, it is necessary to ensure adherence to the Regulatory compliance requirements.
- Regulatory Intelligence Services
- Cosmetic Product Classification
- Cosmetic Formulation Review/ Cosmetics Ingredient Review
- Cosmetic Claims Review
- Cosmetic Label Review as per Mexican Cosmetic Labeling Regulations
Pharma Wizard Expertise
- Pharmaceutical Product Registration
- Authorized Local Agent Representation
- Regulatory Affairs Consulting
- Dossier Gap Analysis as per COFEPRIS Requirements
- Query Response Management until Final Approval
- Ongoing Pharmaceutical Product Compliance & Maintenance
- Ad-hoc Regulatory Consultation
