Case Study: a German pharmaceutical company achieves zero-objection 5-year MA renewal in Mexico with Freyr LATAM

German Pharmaceutical Company secures 5-year MA renewal with zero objections using FREYR

A German pharmaceutical company operating in the vitaminic therapeutic space faced the challenge of renewing its Marketing Authorization (MA) in Mexico without a local regulatory presence. This exposed them to significant risk, as the COFEPRIS process requires a certified local pharmacovigilance unit and proactive lifecycle management that a global team could not provide. The company engaged FREYR to act as its local regulatory arm and manage the full compliance spectrum.

FREYR implemented a solution that included a technical gap analysis, acting as the certified pharmacovigilance unit, and managing the end-to-end submission. This resulted in the successful 5-year MA renewal being secured on the first cycle with zero objections from COFEPRIS. FREYR's work ensured zero market disruption and established a strong compliance platform for the client's future operations in the region.