ROW Labeling

Freyr excels in achieving 100% labeling compliance in ROW markets through expert revision of local product documents, creating high-quality multilingual labels, conducting label comparisons, and ensuring correctness through visual checks, offering comprehensive support in Regulatory Labeling for Market Authorization Holder transfers.

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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.

RoW labeling

  • 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.
  • Develops high-quality labeling content.
  • Expertise in regional regulatory templates.
  • Creates efficient label comparison documentation.
  • Streamlines local label update processes.
  • Harmonizes safety information.
  • Provides visual quality control for translated labels.
  • Offers comprehensive support for MAH transfers.
RoW-labeling-Advantages

Comply with Regional Label Requirements