Labeling – “More than a print on the box”

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