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Zelthy-Variation & Change Management

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What is this product? Zelthy Variation & Change Management is an application for pharmaceutical regulatory teams managing post-approval changes to marketed products. It handles variation classification per jurisdiction-specific rules, submission preparation with required documentation, and cross-jurisdiction tracking to ensure variations are filed consistently across all markets where a product is registered. Key Features & Functionalities - Variation classification per jurisdiction-specific rules - Submission preparation with documentation checklists - Cross-jurisdiction tracking for multi-market variations - Regulatory authority response management - Variation analytics and portfolio reporting Primary Solution & Value Post-approval changes — formulation, manufacturing site, labeling — require regulatory filings (variations) in every market where the product is registered. Different jurisdictions classify the same change differently, with different documentation and timelines. This application manages the complexity of multi-market variation filings, ensuring changes are classified, filed, and tracked consistently across jurisdictions.

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