Increase data quality, global oversight, and control with robust capabilities for product information management, regulatory planning, tracking and data management.

Manages medicinal product data submissions through submission, post-submission, and post-approval according to the IDMP requirements and operating model.

Establish a single content repository for seamless document and content management, including template management, workflows, advanced rendering, and permissions.

Consolidate submissions and publishing workflows in a single solution that makes it simple to create, compile, and publish submissions in any format.

Drive greater efficiency and consistency by streamlining end-to-end labeling change management and compliance tracking workflows.

Leverage a preconfigured set of standard dashboards and reports addressing common regulatory tracking, reporting and analytical needs.

Powered by LifeSphere NavaX for Regulatory, accelerate the intake of Health Authority (HA) communications and build a knowledgebase driving transparency and consistency in HA interactions.

Powered by LifeSphere NavaX for Regulatory, monitor for regulatory updates and build an intelligence knowledgebase to facilitate always up-to-date compliance amid changing regulations.