NEXT Label Lifecycle Automation

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 and machine-assisted label authoring, review and publishing.

It also enables proactive tracking of content deviations across labels, parallel label updates and consolidation, seamless change management across markets, and 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.