Case Study: a South Korea-based pharmaceutical company streamlines LATAM MAA submission for ENVLO with FREYR

South Korea-based Pharmaceutical Company expands ENVLO across 10 LATAM markets with FREYR

A South Korea-based pharmaceutical company sought regulatory support to register their new chemical entity, Enavogliflozin (ENVLO), across multiple LATAM markets. The client faced challenges due to regulatory variability, coordination issues with concurrent processes, and documentation gaps in their initial dossier. FREYR provided comprehensive MAA application support and regulatory operations to address these challenges.

FREYR implemented a solution that included gap analysis, dossier preparation, submission management, translations management, and the development of a tailored Risk Management Plan. This ensured the process was regulatory-compliant and streamlined. As a result, FREYR successfully supported the MAA application across multiple countries, achieving regulatory compliance, significant time and cost savings, risk mitigation, and a successful market entry foundation.