Medical Device Labeling
DEVICES

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

  • Label compliance
  • Artwork design and management
  • SOPs management (create/review/update)
  • Gap analysis for existing labels & Update labels (Inner/outer) as per country requirements
  • Data customization from primary to secondary labels
  • UDI requirements
  • Usage of internationally recognized symbols
  • Life cycle management (post approval services/changes)
  • Local regulatory requirements alignment

Artwork Services

  • Graphics Designing
  • Proof reading
  • End-to-end (Reg intel to content to design)

IFUs (Instructions for use) activities

  • Compliance with new regulations
  • Gap analysis for existing IFUs (deviation management as per country requirements)
  • Create and update the IFUs
  • SOPs management (create/review/update)
  • Life cycle management (post approval services/changes)
  • Literature search

Benefits:

Dedicated Labeling Team

Dedicated labeling teams aligned from a therapeutic perspective

Global FTEs

Global FTEs to match speed and cost

Variable Cost

Allows you to move form fixed-cost to variable cost based on load and activities

Project Management

Operations and project management support for your projects

Want more information? Get in touch with us

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