REGULATORY

 

(Patent-Pending) Labeling Automation for Content & Operations

Ensuring labeling content and processes are standardized and managed in accordance with regulatory perspective is a challenge for both Biopharma innovators as well manufacturers of generics.

While the use of LABELai can reduce cycle time and costs significantly, the primary drivers for its use are Labelling Compliance and reduction of complexity. There is also significant motivation to save time-to-market while holding the integrity of the product and the associated process overheads.

LABELai effectively combines Regulatory breadth, process optimization knowledge with our technical depth utilizing Automation and AI effectively

LABELai functionality:

  • Company Core Data Sheet (CCDS) creation and maintenance (no documents process)
  • Label Master digitization with full Granularity for effective re-usage
  • Regional, local label creation and full lifecycle management (Directly from CCDS/USPI/SmPC)
  • Full cycle SPL built-in with no need of manual SPL generations from USPI
  • Local label conversions as per country specific requirements
  • Labeling for Clinical Trials: Text Phrase management and country-specific Label creation
  • Translation management (both machine and manual for effective re-usability)
  • Label operation & workflow based Tracking of countries implementation with detailed visibility (for Labeling project managers)
  • In-built Document management system (or can connect to your DMS or Content systems)

LABELai Advantages:

DDI’s dedicated labeling content management solution helps life sciences companies

  • Built-in Change control & implementation full cycle
  • Reduce process and content errors at every stage (literally, no QC needed for local labels)
  • Maintain absolute compliance
  • Inbuilt global labeling regulatory intelligence
  • Achieve semi or full Automation
  • Deep Cost savings

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