Mexico stands a favorite destination for medicines and medical device manufacturers to explore the pharmaceutical market opportunities. To do so, manufacturers must obtain approvals from (Comisión Federal para la Protección contra Riesgos Sanitarios) COFEPRIS - The Federal Commission for Protection against Sanitary Risk. Enroute, foreign manufacturers might face challenges navigating the Mexican regulatory regime: Good Manufacturing Practices (GMP) and Pharmacovigilance, and other Regulatory requirements.

Freyr, exclusively focusing on the entire Regulatory value-chain in the region, assists manufacturers to be abreast with the Mexican Regulatory requirements and mandatory obligations. Freyr’s Regulatory services in Mexico span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Market Authorizations
  • Gap analysis
  • Dossier preparation and maintenance of variations, renewals
  • Dossier Submissions
  • NTA to CTD conversions
  • Labeling
  • Medical writing
  • Good Compliance Practice (GCP)
  • Company Core Data Sheets (CCDS)
  • Periodic Safety Update Report (PSUR)

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with COFEPRIS, MOH
  • Team with 25+ years of strong foothold in the region
  • Proven track record for device registrations and submissions
  • End-to-end cosmetic Regulatory consultation
  • Structured and cost-effective approach to ensure speed to market