Case Study: a German pharmaceutical company renews Mexico marketing authorization with Freyr LATAM

German Pharmaceutical Company renews MA for 5 years with FREYR

A German pharmaceutical company operating in the vitaminic therapeutic space needed to renew a Marketing Authorization in Mexico to maintain market continuity, facing strict COFEPRIS regulations and tight timelines. They turned to FREYR for local lifecycle management expertise and pharmacovigilance unit (UPV) services to navigate the complex submission and compliance requirements.

FREYR deployed a local team to conduct a gap analysis, act as the certified pharmacovigilance unit, and prepare and submit all required reports. This solution provided by FREYR led to the successful 5-year MA renewal with 100% first-cycle compliance and zero market disruption, ensuring ongoing product commercialization and building client confidence for future initiatives in the region.