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Pharmaceuticals Expertise

  • Pharmaceutical Product Registration
  • Authorized Local Agent Support  
  • Regulatory Affairs Consulting
  • Gap Analysis of the Dossier as Per COFEPRIS Regulatory Requirements. 
  • Query Support Management till Approval 
  • Pharmaceutical Product Compliance & Maintenance
  • Ad-hoc Regulatory Consultation
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Overview of the Mexican
Regulatory Landscape

Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios), popularly known as COFEPRIS, is the National Health Authority in Mexico. COFEPRIS is the vertex of all Regulatory bodies governing the registration of Medical Devices, Cosmetics and Food Supplements, and Pharmaceutical Product Registration in Mexico. It is responsible for production, distribution, commercialization, imports and exports, advertisement, sales, and supply of these products. COFEPRIS has control over the general disposition, safety sanctions, sanitary control, and health promotions of all the medical products in the country.

 

Industries We Serve

The “Comisión Federal para la Protección Contra Riesgos Sanitarios” (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 COFEPRIS
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Federal Commission for the Protection against Sanitary Risk (Comisión Federal para la Protección contra Riesgos Sanitarios), popularly known as COFEPRIS, falls under the Ministry of Health (MoH) and regulates the medical devices marketed in Mexico. The Sanitary Authorization Commission evaluates the COFEPRIS medical device Registration Applications, whereas the Sanitary Operations Commission is responsible for auditing the warehouse and other facilities located in Mexico.

  • End-to-end Mexico Medical Device Approval Services 
  • Medical Device Compliance in Mexico 
  • Sanitary Responsible Person (SRP) Services 
  • Application Submission to COFEPRIS 
  • Query Support Management till Approval 
  • Post-approval Device Life Cycle Management 
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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
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The Mexican cosmetics market is amongst the top revenue grossers across the globe. With a growing demand for cosmetic products among the country’s 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.

  • Regulatory Intelligence Services
  • Cosmetic Product Classification
  • Cosmetic Formulation Review/ Cosmetics Ingredient Review
  • Cosmetic Claims Review
  • Cosmetic Label Review as per Mexican Cosmetic Labeling Regulations 
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

Australia
Australia
Australia
Sri Lanka
Sri Lanka
Sri Lanka
Argentina
Argentina
Argentina
Bangladesh
Bangladesh
Bangladesh
Hong Kong
Hong Kong
Hong Kong
Malaysia
Malaysia
Malaysia
Mexico
Mexico
Mexico
Philippine
Philippine
Philippines
Russia
Russia
Russia
Ukraine
Ukraine
Ukraine
Singapore
Singapore
Singapore
Taiwan
Taiwan
Taiwan
Vietnam
Vietnam
Vietnam
Venezuela
Venezuela
Venezuela
Nigeria
Nigeria
Nigeria
Paraguay
Paraguay
Paraguay

Location

Calle Jose Bernardo Couto 87, Colonia Mexico, Nezahualcoyotl, Estado de Mexico – CP. 57620

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