What we offer
Transformation of enterprise-wide labeling data and operations, by leveraging AI and advanced analytics, with a focus on ways to generate, contextualize and publish labels for consumption by patients and HCPs
Who is it for
Regulatory and labeling teams, including their global and local affiliates
Why it’s important
Simplify enterprise-level management of label life cycles
Create downstream labels faster with content reuse
Manage label content and timeline compliance proactively across markets
How we deliver
Process
Our enterprise technology-led solution uses AI-based automation along with deep labeling domain expertise to drive simplified, efficient, and compliant label submissions, through
- Unified enterprise-level management of labeling lifecycles
- Automated classification of labeling data into reusable modules
- Machine-assisted label authoring, review and publishing
- Proactive tracking of content deviations across labels
- Parallel label updates and consolidation
- Seamless change management across markets
- Change management against Health Authority feedback
The solution is adaptable and scalable to emerging regulatory needs for life sciences labels; including IDMP, SPL, SPM and ePI.
What makes us different
One stop solution to manage complete label lifecycle from content to submissions
Custom-built for label functions by leveraging deep domain expertise and technology know-how
