EP2AS VUE
Next-Generation Review and
Submission Management,
Built for eCTD v4.0
Manage every eCTD package in real time, in the cloud or on-premises, from a single platform. eP2AS VUE brings together team collaboration, document tracking, and progress management for complex regulatory submissions.
EP2AS VUE — BEHAVIOR LOGS / ORGANIZATION SETTING
Key Features
Submission project and milestone management with Gantt charts
Status and version tracking at the CTD module level
Electronic approval workflows (eSign), 21 CFR Part 11 compliant
Simultaneous management of multi-region submissions (Japan, US, EU)
Automatic notification and response tracking for review queries
Automated executive reporting and KPI dashboards
Integration APIs for external systems (DMS/RIM)
Strict cross-organization access controls with detailed activity logs
Where eP2AS VUE Fits In
Regulatory Affairs Teams at Pharmaceutical Companies
Manage submission projects across multiple products and regions in one place with VUE. Progress visibility helps speed the path to approval.
Global Submission Teams
Track simultaneous submissions across Japan, the US, Europe, and Asia in VUE, with country-by-country status and deadlines visible in a single view.
CDMOs / CMOs
Give overseas small and mid-sized pharma clients without their own eCTD v4.0-capable viewer a secure environment for sharing and reviewing submission data — helping you stand out to domestic MAHs looking for a new contract partner.
eP2AS VUE handles submission visibility and progress management. If you’re evaluating options as a new customer, we recommend Miyabira as a more comprehensive platform covering everything from validation through process management.