Business Imperatives

A South Korea-based pharmaceutical company sought regulatory support to register their new chemical entity, ENVLO (Enavogliflozin), across multiple LATAM markets. The company required end-to-end assistance—from documentation alignment to submission coordination—for simultaneous market access.

Objectives

To enable the successful submission and approval of a new chemical entity in LATAM through comprehensive MAA application support and regulatory operations.

Problem Statement

 The client faced the following challenges:

  • Regulatory Variability: Difficulty aligning documentation with varying LATAM regulatory standards.
  • Coordination Issues: Managing multiple concurrent processes such as translation and dossier preparation.
  • Documentation Gaps: Inconsistencies and non-compliant data across the initial dossier.

Freyr Solutions and Services

Freyr Solutions and Services
  • Gap Analysis: Identified key documentation gaps based on regional regulatory requirements.
  • Dossier Preparation: Developed a technically compliant dossier for submission across target LATAM countries.
  • Submission Management: Oversaw end-to-end submission processes and maintain communication with Health Authorities (HAs).
  • Translations Management: Ensured accuracy in the translation of critical documents across markets.
  • RMP Development: Tailored a Risk Management Plan specific to LATAM regulatory frameworks.
  • Regulatory Compliance: Adherence to local Health Authority standards improved approval potential.
  • Time & Cost Savings: Optimized workflows reduced rework and shortened submission timelines.
  • Risk Mitigation: Proactive documentation and translation management minimized approval risks.
  • Successful Market Entry: Achieved a strong regulatory foundation for product launch across multiple LATAM countries.

Freyr ensured that the MAA application process was regulatory-compliant, coordinated, and streamlined across LATAM markets including Colombia, Peru, Ecuador, Costa Rica, Guatemala, Panama, Honduras, El Salvador, and the Dominican Republic.