Label activities that we perform
- Label content development utilizing our medical affairs, labeling and regulatory teams
- Label design and management
- Labeling 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 compliance o various regions
- 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
- Develop and design content for IFUs
- Compliance with new regulations
- Gap analysis for existing IFUs (deviation management as per country requirements)
Benefits
- Dedicated labeling teams aligned from a therapeutic and risk class perspective
- Global FTEs from our Labeling Center of Excellence to match speed and cost
- Allows you to move form fixed-cost to variable cost based on load and activities
- Operations and project management support for your projects
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