Pharmaceutical – LAbeling

Our model provides highly qualified, fully vetted labeling specialists to tackle a wide variety of labeling projects. 

End-to-End Product Labeling Development

  • Develop and maintain Target Product Profile (TPP), Company Core Data Sheet (CCDS), Company Core Patient Prescribing Information (CCPPI)
  • Author and review local/regional labeling
    • US Prescribing Information (USPI/US Patient Prescribing Information (USPPI)
    • EU Summary of Product Characteristics (SmPCs)/Patient Information Leaflets
    • Canadian Product Monograph
    • Medication Guides, Instructions for Use
  • Content for container and carton labels to meet regional regulatory requirements
  • Ensure consistency between labeling, labels and supportive documents

Leading Cross-Functional Teams for Label Development and Review

  • Provide labeling strategic insight to teams
  • Author labeling documents for team review and consensus
  • Labeling review and compliance to relevant regulations
  • Evaluate and communicate risks
  • Regulatory assessment of labeling changes

Health Authority Interactions

  • Regulatory Agency liaison, including agency meeting support
  • Structured Product Labeling (SPL) conversion and submission

Labeling Operations

  • Proofreading and Quality Control checks
  • Management of packaging and bottle labeling artwork files
  • Rebranding of cartons, labels and revision of graphics
  • Design, create, and update Adobe Illustrator and InDesign files for Cartons, Labels and PILs
  • Create change notice, describe rationale, collect and attach supporting evidence
  • Manage change notice through approval and closure
  • Coordinate directly with print suppliers to securely transfer files

Assessment of Existing Labeling Process and System

  • Gap Analysis for regulatory compliance
  • Analysis of labeling roles and responsibilities
  • Development of global procedures

Implementation of Content and Artwork Management Systems for Labeling

  • Conduct a Risk Assessment for System Requirements
  • Create User Requirement Specification (URS)
  • Data clean-up and migration
  • Software Validation (PQ)
  • Finalize process and procedure development
  • Label format and verification
  • Go-live strategies and support