Labeling Services

  • End‑to‑end Product Labeling development
    • Target Product Profiles (TPP)
    • Company Core Data Sheets (CCDS/CDS) and Company Core Patient Prescribing information (CCPPI)
    • US Prescribing Information (USPI) and US Patient Prescribing Information (USPPI)
    • EU Summary of Product Characteristics (SmPCs) and Patient Information Leaflets (PILs - Centralized, MRP, National)
  • Lead cross‑functional and therapeutic area groups for label development and review
  • Develop/review Medication Guides, Instructions for Use
  • Provide labeling insight and strategy to teams to arrive at consensus
  • Labeling review and compliance
  • Health Authority interactions and negotiations
  • Support Regulatory Agencies requiring labeling information
  • Legacy product support for all countries
  • Line extensions
  • Proofreading and departmental QC
  • Labeling Operations (Packaging, bottle labeling, artwork systems)
  • Technical/SPL

Request for Labeling Services

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