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 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’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 harmonization of safety information, creating reduced PI (Mexico), and label hard-track changes for variations (South Africa) while assisting in labeling activities for Market Authorization Holder (MAH) transfers.
- Developing high-quality labeling content for local markets
- Meeting template and formatting requirements
- Creation of label comparison table for Regulatory submissions
- Identification of Reference Safety Information (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 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.
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