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Pharmaceuticals Registration in Mexico (COFEPRIS)

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Mexico

‘After Brazil, Mexico has the second largest pharmaceutical market in Latin America. With more than 11 billion units of products sold in 2019, the country’s wholesale pharmaceutical industry reached a revenue of more than 174 billion Mexican pesos, or approximately 8.4 billion U.S. dollars.’ Statista

 

Pharmaceutical products are regulated by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) in Mexico.

 

Artixio’s regional presence in Mexico and experience with pharmaceutical products compliance in the country has helped our clients access the market to register and introduce their pharmaceutical products in Mexico. We can support through entire product lifecycle using regulatory advisory and operational services for new molecules, generic drugs, biologics and biosimilars.

 Regulatory Strategy & Intelligence

Artixio’s regional regulatory experts provide insights into Mexico regulations for pharmaceutical and biologic products right from development to authorization. Depending on the stage you are in of your journey, our team can provide you evidence based strategic insights to make suitable decision for successful product registration in Mexico. Our services include,

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  • Insights on Mexico’s Regulations for New Molecules, Generics, Biologics, Biosimilars and Combination products

  • Consultation on Regulatory Pathway for your product and therapeutic indication

  • GMP and audit requirements based on your existing approvals in other countries

  • Insights on pricing, market opportunity, distribution channels and cost of landing the product

  • COFEPRIS consultation strategy  

Regulatory Affairs Services in Mexico

Our experience with COFEPRIS and regional experts support our clients with end to end registration of pharmaceutical and biologic products in Mexico. Our services include,

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  • Dossier gap analysis based on existing approvals in reference markets (USA, EU, Australia etc.)

  • Dossier preparation for COFEPRIS submission

  • Consultation meeting with COFEPRIS

  • Response to queries

  • Obtaining license post approval  

Regulatory Operations

Our regulatory operations services support pre and post registration of pharmaceutical products.

  • Notarization where applicable

  • Translation in Spanish

  • Regulatory Information Management

  • Post Approval Maintenance such as license renewals, annual reports

Market Intelligence

Artixio enables data driven executive decisions across C-Level, marketing, R&D, clinical, regulatory and commercial department right from product development, product launch and post marketing support. Our team has decades of experience and insights to global markets in planning and commercializing pharmaceutical, med-tech, cosmetic and nutrition products.

 

Our comprehensive market intelligence approach covers all key areas of life-sciences products to enable critical commercial decisions for,

  • Develop key product differentiators and product development plan

  • Competitor analysis (business, Intellectual Property, clinical, product claims/benefits etc) and developing counter competitive strategies

  • Market landscape analysis to

    • quantify market opportunity and market size

    • identify key sales and distribution channels (pharmacy and retail sales, hospital sales, salons/spas, online ecommerce and others)

    • Develop country specific product launch strategy – product portfolio selection, pricing, sales/distribution channels, marketing messages, marketing collateral requirements, regional Key Opinion Leaders, consortiums and events

  • Assess target market and key market positioning

  • Develop key marketing strategy and marketing messages

  • Pricing benchmarking for product positioning and value proposition

  • Disease Area Strategy based on therapeutic area landscape analysis, therapeutic modalities and cost of treatment

  • Clinical Intelligence to assess competitors’ product development and clinical strategy to develop a differentiated clinical development roadmap

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