COFEPRIS Lifecycle Demands for a German Pharmaceutical Company

Business Imperatives

A German-headquartered pharmaceutical company, operating in the vitaminic therapeutic space, needed to maintain market continuity in Mexico by renewing a Marketing Authorization (MA) under COFEPRIS.

Given the complexity of Mexico’s regulatory landscape and strict pharmacovigilance obligations, the client sought:

Local lifecycle management expertise with deep knowledge of COFEPRIS standards
End-to-end support for safety reporting and MA submission
Seamless integration with global RA operations despite time zone differences

Objectives

Achieve the 5-year renewal of the product’s MA with zero delays or objections
Ensure full regulatory compliance under COFEPRIS guidelines
Prevent any disruption to product commercialization in Mexico

Problem Statement

The project involved several pressing challenges:

Tight submission timelines with little margin for error
Misalignment between global dossier format and local COFEPRIS requirements
Need for certified local pharmacovigilance representation (UPV)
Lack of in-country regulatory presence to manage day-to-day coordination

Freyr Solutions and Services

Freyr LATAM deployed a dedicated local team to provide full-spectrum regulatory lifecycle support. Key activities included:

Conducted a technical gap analysis to align documentation with COFEPRIS expectations
Acted as the client's certified Pharmacovigilance Unit (UPV) in Mexico
Prepared and submitted the Periodic Safety Report (PR)
Validated all regulatory components under updated national guidelines
Maintained consistent communication with global RA teams across time zones

Benefits

Trusted partnership between Freyr LATAM and global stakeholders
Proactive identification and resolution of documentation gaps
Preventive compliance ensured cost and time savings
Strengthened regulatory readiness for future submissions and expansions in LATAM