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IDMP is a suite of five standards developed within the International Organization for Standardization (ISO). These standards provide an internationally accepted framework to uniquely identify and describe medicinal products with consistent documentation (including labeling), coding and exchange of product information between global regulators, manufacturers, suppliers and distributors.

How does Kallik help with IDMP?

Kallik helps pharmaceutical manufacturers prepare for IDMP compliance by preserving labeling content as structured data. Because Veraciti™ stores, indexes and versions every piece of labeling content ever created and maintains a record of which labels use which content, the risk of downstream labeling becoming out of alignment with submission data is greatly reduced.

 

  • Captures and manage the relationship between the data elements that form part of the package description and the underlying data that forms part of the labeling content

 

  • Establishes a single source of labeling ‘truth’ that all market-facing product information and materials flow from

 

  • Facilitates the reliable exchange of structured regulatory content contained within product and package labeling in a robust and consistent manner

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