REGULATORY

 

Labeling Automation

Ensuring that labeling content and processes are standardized and updated in accordance with regulatory updates is a challenge for both pharma innovators and manufacturers of generics.

While the use of LABELai you can reduce cycle time and costs, the primary drivers for its use are label accuracy and quality. Error-free data submitted to regulatory agencies during the approval process prior to a product’s release to market is critical for its success. There is also significant motivation to save time-to-market — while holding the integrity of the product — and the associated process costs.

By implementing LABELai, differences are automatically highlighted between the documents, significantly reducing operational costs, and improving quality and time-to-market due to the steep reduction of human intervention.

LABELai The only labeling tool that uniquely combines creation of labeling content matching regulatory guidelines with business rules built in, utilizes NLP for pdf/word documents reading and developed with core labeling teams in mind.

LABELai tool functionalities:

  • Company Core Data Sheet (CCDS) creation and updation
  • Regional, local label creation and updation
  • LMD (SmPC & USPI) creation and updation
  • Local label conversions as per country specific requirements
  • Document management system (CCDS/SmPC/USPI)

LABELai tool Advantages:

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

  • Build quality into your process
  • Reduce risk of errors at every stage
  • Maintain absolute control and compliance
  • Manage the challenges of controlling your labeling copy and content
  • Inbuilt with global labeling regulatory knowledge
  • Handles global and regional drug labeling support to top pharma clients, worldwide

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