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Freyr 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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Greetings from Freyr Mexico

Freyr is one of the largest global, Regulatory-focused solutions and services companies. We support Life Sciences companies entering Mexican Pharma Market in their entire Regulatory value chain, ranging from Regulatory strategy, market intelligence, local representation, and post-approval product maintenance functions.

The 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. The COFEPRIS is the vertex of all Regulatory bodies governing the registration of medical devices, cosmetics, food supplements, and pharmaceutical products registration in Mexico. With our on-ground team of Mexican experts, we support you in obtaining approvals from the COFPRIS and ensuring a smooth market entry of your products in Mexico.

 

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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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 (Comisión Federal para la Protección 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
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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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Freyr Digital

Freyr SUBMIT PRO
Freyr SUBMIT PRO, an eCTD Software, Suits All Your Submission Requirements
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Freyr IMPACT
An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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Freyr iReady
Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence Know More

 

Freyr PRISM
Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
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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

We are a global firm and we have local expertise across the following countries.

Brazil
Brazil
Brazil
Paraguay
Paraguay
Paraguay
Nigeria
Nigeria
Nigeria
Venezuela
Venezuela
Venezuela
Thailand
Thailand
Thailand
Russia
Russia
Russia
Singapore
Singapore
Singapore
Taiwan
Taiwan
Taiwan
Vietnam
Vietnam
Vietnam
Philippines
Philippines
Philippines
Hong Kong
Hong Kong
Hong Kong
Egypt
Egypt
Egypt
Sri Lanka
Sri Lanka
Sri Lanka
Argentina
Argentina
Argentina
Bangladesh
Bangladesh
Bangladesh
China
China
China
Malaysia
Malaysia
Malaysia
Australia
Australia
Australia
India
India
India
Ukraine
Ukraine
Ukraine
Saudi Arabia
Saudi Arabia
Saudi Arabia
Japan
Japan
Japan
South Korea
South Korea
South Korea

Location

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

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