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Labeling – “More than a print on the box”

Label activities that we perform

  • BulletLabel content development utilizing our medical affairs, labeling and regulatory teams
  • BulletLabel design and management
  • BulletLabeling SOPs management (create/review/update)
  • BulletGap analysis for existing labels & Update labels (Inner/outer) as per country requirements
  • BulletData customization from primary to secondary labels
  • BulletUDI compliance o various regions
  • BulletUsage of internationally recognized symbols
  • BulletLife cycle management (post approval services/changes)
  • BulletLocal regulatory requirements alignment

Artwork Services

  • BulletGraphics Designing
  • BulletProof reading
  • BulletEnd-to-end (Reg intel to content to design)

IFUs (Instructions for use) activities

  • BulletDevelop and design content for IFUs
  • BulletCompliance with new regulations
  • BulletGap analysis for existing IFUs (deviation management as per country requirements)

Benefits:

  • BulletDedicated labeling teams aligned from a therapeutic and risk class perspective
  • BulletGlobal FTEs from our Labeling Center of Excellence to match speed and cost
  • BulletAllows you to move form fixed-cost to variable cost based on load and activities
  • BulletOperations and project management support for your projects

 

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