Pharmaceutical
Labeling
Services
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
