Regional Labeling Rest of the World (RoW) :  Overview

To enable clients to achieve 100% labeling compliance in the regional labeling Rest of the World (RoW) markets, Freyr leverages expertise in regional Regulatory template requirements and performs a comprehensive revision of the existing local product documents to create high-quality multilingual regional labels. Freyr has proven expertise in Regulatory Labeling Rest of the World (RoW) by creating multiple label comparison documents and assessment summaries and efficiently steers the selection of Reference Safety Information (RSI) for the standardization of Pharmacovigilance (PV) activities. 

Freyr’s Regulatory Labeling Rest of the World (RoW) experts perform a visual check of translated regional labels to ensure correctness as part of the Quality Control (QC) exercise. We also help companies in the harmonization of safety information, creating reduced PI (Mexico), and labeling hard-track changes for variations (South Africa) while assisting in Regulatory labeling activities for Market Authorization Holder (MAH) transfers.

Regional Labeling RoW - Freyr Expertise

  • Developing high-quality labeling content for local markets.
  • Meeting template and formatting requirements for regional labels.
  • Creation of label comparison table for Regulatory submissions.
  • Identification of Reference Safety Information (RSI) for standardization of PV activities.
  • Creation of local label update process (including SOPs and Work Instructions).
  • Harmonization of safety information.
  • Visual QC of translated regional labels.
  • Creation of concise PI (Mexico).
  • Label creation with hard-track changes for variations (South Africa).
  • Labeling activities for MAH transfers.
  • Regional Prescribing Information (RPI) preparation.
  • RPI variation management.

Comply with Regional Label Requirements

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