Overview
Labeling is an interdisciplinary function that serves as the basis on which the prescribing information, advertising, and promotional materials for the medication are henceforth created. Biopharmaceutical product labeling is a complex process that involves multiple products and markets for different formulations and dosages, maintaining labeling compliance throughout the process.
To effectively maintain the safety and efficacy of a drug, tracking and harmonization of labeling information is essential for pharmaceutical companies. An effective and robust labeling system should ideally include a defined process, tracking tools, and well-trained labeling professionals upholding the practices of labeling compliance.
Freyr has extensive experience in setting up and implementing labeling compliance processes, creating Core Patient Information Leaflet (Core PIL), and auditing the existing labeling setups to ensure labeling compliance.
Freyr Expertise
Strategy Consulting
- Business/Process/Technology strategy consulting
- Global label management Standard Operating Procedure (SOP) creation
- Audit consulting, preparedness assessment, and support
- Label management business process consulting
Technology Consulting & Implementation
- Insight-driven, cutting-edge technology consulting
- Global compliance label management technology development & implementation
Operational Support
- Core data sheet authoring, review, and approval coordination
- CDS impact on local labels and local label updates
- Global label change management
- Signal impact assessment
- Manage and update the global label management tool
- Track potential impact on ROW labels
- Establish a process to track changes in timely submissions (based on urgent/non-urgent timelines)
- Track implementation status
- Track submission timelines
- Harmonize safety information
- Identify internal and external signal detection and innovator label changes (signal management)
- Assess the safety updates and signals from one region/country and their impact on other regions/countries
- Assess the safety & non-safety updates across markets
- Creation of Core PIL
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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