Solutions

Optimized regulatory Labeling solutions from inception to implementation including the following but not limited to:

  • Target Product Labeling (TPL)
  • Company Core Data Sheet (CCDS)
  • United States Prescribing Information (USPI)
  • Summary of Product Characteristics (SmPC)
  • Patient Labeling
  • Instructions of Use
  • User Testing
  • Readability Testing
  • Labeling Process Development
  • Implementation of Core Labeling in Regional Labeling
  • Labeling Negotiations with the Health authorities
  • Labeling Deviations Tracking
  • Labeling Competitive Intelligence
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