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2. 2 A prescription drug product label is a compilation of information about the safe and effective use of the product prepared by the manufacturer or marketing authorizing holder (MAH) and approved by the health authorities in the respective marketed zones. Drug labeling is becoming more prominent that involves dealing with multiple functional dynamics with required specialized attention, stakeholders (supply chains), and constantly evolving regulatory environment across the globe. Marketing authorization holder is responsible to maintain the valid and updated information in their approved or marketed product labels throughout of its lifecycle globally where the products are being marketed. Labeling Digitization: Manage Data, not Documents

3. 3 www.DDIsmart.com Company Core Data Sheet (CCDS) & IFU - creation and maintenance Local Labels generated automatically from any of master document CCDS, IFU, SPC and USPI documents Regulatory Intelligence built-in for 50+countries SPL creation and updating Full manual/machine translation built-in Compliance check for local label deviations and local deviation safety compliance E2E Tracking with Change control and Label Operations Built-in EDMS (or can integrate to yours) and BPM (for workflows) Some Key Features of LABELai

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