What is this product?
Zelthy Labelling Management is an application for pharmaceutical regulatory teams managing product labeling across markets. It maintains the core data sheet as the single source of truth, manages local market label adaptations per jurisdiction requirements, coordinates artwork changes with packaging teams, and assesses the impact of labeling changes across all registered markets — ensuring consistency across the global label portfolio.
Key Features & Functionalities
- Core data sheet management as single source of truth
- Local market label adaptation per jurisdiction requirements
- Artwork coordination with packaging teams
- Change impact analysis across registered markets
- Label version control and approval workflows
Primary Solution & Value
A single labeling change can affect dozens of markets, each with different regulatory requirements for implementation. Without structured change management, labeling inconsistencies across markets create compliance risk. This application manages the cascade from core data sheet change through local adaptations, ensuring every market's label remains consistent and compliant.