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Labeling – “More than a print on the box”

We all know the labeling definition well and that includes any part of written, printed, packaging and Graphics matter that accompanies the product.

Key is to keep this in compliance and updated at all times in all countries as Health Authorities primary concern remains patient access to high quality, safe and effective, and avoiding access to products that are unsafe.

MakroCare’s Global Labeling team provides advisory and implementation services to ensure your compliance maintained at all times, whether it’s local country labels or international.

With our global teams consisting of Physicians, regulatory experts, artwork, packaging and operations resources, clients can leverage full outsourcing or complimentary tactical project models.

Label activities that we perform

  • BulletLabel compliance
  • BulletArtwork design and management
  • BulletSOPs management (create/review/update)
  • BulletGap analysis for existing labels & Update labels (Inner/outer) as per country requirements
  • BulletData customization from primary to secondary labels
  • BulletDI requirements
  • 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

  • BulletCompliance with new regulations
  • BulletGap analysis for existing IFUs (deviation management as per country requirements)
  • BulletCreate and update the IFUs
  • BulletSOPs management (create/review/update)
  • BulletLife cycle management (post approval services/changes)
  • BulletLiterature search

Benefits:

  • BulletDedicated labeling teams aligned from a therapeutic perspective
  • BulletGlobal FTEs 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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