To enable clients to achieve 100% labeling compliance in the Rest of the World (RoW) markets, Freyr leverages expertise in Regulatory template requirements for regional labels and performs a comprehensive revision of the existing local product documents to create high-quality multilingual regional 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 standardization of Pharmacovigilance (PV) activities. 

Freyr’s 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 change for variations (South Africa) while assisting in labeling activities for Marketing Authorization Holder (MAH) transfers.

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 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 reduced PI (Mexico)
  • Creation of label with hard-track changes for variations (South Africa)
  • Labeling activities for MAH transfers
  • Regional Prescribing Information (RPI) preparation
  • RPI variation management


To streamline end-to-end Regulatory labeling practice from creation to tracking to managing in company of any size, Freyr offers a centralized labeling life cycle management software, Freyr LABEL. Right from creating, tracking and managing company core data sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting. Freyr LABEL puts companies in total control of all their Regulatory labeling compliance needs.

Would you like to decode complete information and gain a first-hand experience of Freyr LABEL?


Global HA Mandates