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REGULATORY

 

Pharma Labeling system

(Patent-Pending) Next Generation Labeling Automation Platform

LABELai is a patent-pending tool that enables companies achieves their End-to-End regulatory labeling goals. With option of using the system for either Label Content Management or Label Operations or both, companies can pick the part of the tool that enhances their productivity and efficiency.

Content part ensures top-down approach linking content and operations seamlessly. LABELai utilizes Artificial Intelligence and NLP business rules internally coupled with local country requirements (Reg Intel built-in) and all of this delivered in a cloud platform to reduce IT burden drastically. In turn, all label aspects managed automatically without manual efforts. With the use of an automated tool, labeling teams can reduce time, costs and non compliance challenges.

End to End (E2E) Label Operations

  • Manage labeling operations from content to local operations to supply chain
  • Workflow based with “no programming” involved for agility
  • Metrics management and detailed reports/dashboards for different stake holders
  • “Light processes” for non-core labeling teams like local RA, artwork or supply release teams
  • Built-in project and program management
Pharmaceutical Labeling Software

Label Content Automation

  • Provides end to end labeling such as CCDS create/update, SmPC/USPI create/update, and LPDs
  • Company Core Data Sheet (CCDS) - creation and updating. Maintain Core package automatically
  • Automating local label creation from any of CCDS or as most companies prefer instead use SPC / USPI as source documents.
  • Reg Intel built-in for 50+ countries (and you can bring in your custom country requirements as well)
  • Structured Product Label (SPL) creation and updating
  • Full Local labels Life cycle management including translation processes
  • Label tracking, safety compliance and version history reports
  • 100% Label QC automation

Global Labeling Compliance

  • Compliance checks for local label deviations and local deviation safety compliance
  • Set rules/controls for alerts on deviations
  • One-click reports to get any deviation on any product in any country

Labeling Strategy

  • Access to 35k+ approved marketed products labels
  • Compare different versions and 3rd party labels as well
  • Load any USPI or SmPC and do side-by-side comparison on the fly

Key Benefits:

  • All teams full empowered reducing too many dependencies and manual handoffs
  • Built-in Change control & implementation full cycle
  • Leverage built-in automation to gain efficiency
  • Reduce process and content errors at every stage (literally, no QC needed for local labels)
  • Maintain absolute compliance
  • Inbuilt global labeling regulatory intelligence
  • Deep Cost savings

To Know More about DDi's LABELai, a patent pending Drug & Device Labeling Automation Software, and to take a feature-specific comprehensive product tour.

Request a Demo

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Useful Resources

Blog
Challenges with Labeling Content, QC & Tracking - The Way Out

Challenges with Labeling Content, QC & Tracking -

Read More

Blog
Label Tracking: An Important Aspect In Production Distribution

Label Tracking: An Important Aspect In Production Distribution

Read More


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