ROW Labeling

Freyr achieves 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 MAH transfers.

Regional Labeling Rest of the World (RoW) - Overview

To enable clients to achieve 100% labeling compliance in the 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 in the Rest of the World (ROW) markets. We create multiple label comparison documents and assessment summaries, and efficiently steer the selection of Reference Safety Information (RSI) for the standardization of Pharmacovigilance (PV) activities.

Freyr’s Rest of the World (ROW) Regulatory labeling 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.

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