Labeling is an interdisciplinary function that serves as the basis on which prescribing information, advertising and promotional materials for the medication are henceforth created. Biopharmaceutical product labeling is a complex process which involves multiple products and markets for different formulations and dosages. Tracking and harmonization of labeling information, to effectively maintain the safety and efficacy of a drug, is essential for pharmaceutical companies. An effective and robust labeling system should ideally include a defined process, tracking tools and well-trained labeling professionals.
Freyr has extensive experience in setting up and implementing labeling process, creation of Core Patient Information Leaflet (Core PIL) and auditing existing labeling setups to ensure labeling compliance.
- 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 label management technology development & implementation
- Core data sheet authoring, review and approval coordination
- CDS impact on local labels, 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 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 safety & non-safety updates across markets
- Creation of core patient information leaflet (Core PIL)
- Resources with in-depth Regulatory knowledge
- Expertise in successfully handling global and regional drug labeling for Fortune Pharma clients across the globe; USA, EUROPE, APAC, MENA etc.
- Global Regulatory expertise in covering life sciences organizations viz. Pharma, Biotech, and Nutrition manufacturers
- Highly qualified medical writers possessing extensive Regulatory labeling experience
- In-depth and updated understanding of the global drug labeling changes from multiple Health Authorities such as: USFDA, EMA, TGA etc.
- Dedicated Regulatory labeling compliance team tracking the status of core and company core data sheet (CDS / CCDS) implementation in regional labels
- Highly experienced Pharmaceutical, Biotech and Nutrition labeling professionals
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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