Overview

To enable clients to achieve 100% labeling compliance in 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 labels. Freyr has proven expertise in creating multiple label comparison documents and assessment summaries, and efficiently steers the selection of Reference Safety Information (RSI) for the standardisation of Pharmacovigilance (PV) activities. 

Freyr labeling experts does a visual check of translated labels to ensure correctness as part of quality control (QC) exercise. We also help companies in harmonization of safety information, creating reduced PI (Mexico), label hard track changes for variations (South Africa) while assisting in labeling activities for market authorization holder (MAH) transfers.

Freyr Capabilities

  • Developing high quality labeling content for local markets
  • Meeting template and formatting requirements
  • Creation of label comparison table for Regulatory submissions
  • Identification of RSI for Standardisation of PV activities
  • Creation of Local label update process (including SOP’s and Work instructions)
  • Harmonization of safety information
  • Visual QC of translated labels
  • Creation of reduced PI (Mexico)
  • Creation of label with hard track changes for variations (South Africa)
  • Labeling activities for MAH transfers
  • RPI preparation
  • RPI variation management