Freyr Solutions Mexico is a premier global provider of regulatory-focused solutions and services, dedicated to supporting life sciences organizations in navigating the complex regulatory landscape of Mexico. As part of the internationally recognized Freyr Solutions group, the Mexico division specializes in offering end-to-end regulatory affairs, compliance, and market access services for companies in pharmaceuticals, medical devices, cosmetics, food supplements, and related sectors.

Operating with a deep understanding of Mexican regulatory requirements, particularly those set by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), Freyr Solutions Mexico empowers clients to achieve seamless and compliant entry into the Mexican market. The company’s team of local regulatory experts and industry specialists provides tailored support at every stage of the product lifecycle—from initial strategy and market intelligence to dossier preparation, submission, and post-approval maintenance.

Freyr Solutions Mexico stands out for its commitment to quality, transparency, and client-centric service. The company assists both multinational corporations and local businesses, ensuring that products meet all necessary safety, efficacy, and labeling standards. By leveraging advanced digital regulatory platforms and a global knowledge base, Freyr Solutions Mexico delivers efficient, cost-effective solutions that reduce time-to-market and mitigate compliance risks.

With a proven track record of successful regulatory submissions and long-term partnerships, Freyr Solutions Mexico is the trusted partner for life sciences companies seeking to expand their footprint in Mexico.

• Regulatory Affairs Consulting

• End-to-End Registration Support for pharmaceuticals, medical devices, cosmetics, and food supplements

• Authorized Local Agent Support (Mexico Registration Holder)

• Strategic Regulatory Guidance during product development

• Gap Analysis, dossier review, compilation, and submission to COFEPRIS

• Post-approval product maintenance and compliance management

• Regulatory intelligence and market entry strategy

• Food product classification, formula review, and labeling compliance

• Cosmetic product compliance, claims review, and ingredient assessment

• Digital regulatory platforms including eCTD submission software and regulatory information management solutions1

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