Features | Benefits |
- Preconfigured Registration Dossier Templates for CTD/eCTD Structure
- Assembly & Submission Publishing in PDF and eCTD Format
- CTD (PDF) and eCTD Publishing from the Same Structure
- Comprehensive Submission Lifecycle Management
- Integrated Content Management
- Scan/Input CaptureTechnology
- Built in Support for National,Centralized, Decentralized and Mutual RecognitionProcedures
- Universal Web Client
- Implementation of Formal Document Lifecycles
- 21 CFR Part 11 Compliant EU
- GMP Annex 11 Compliant
| - Total Integrated Solution for Regulatory Affairs
- Lower Total Cost of Ownership
- Improved Efficiency
- Increased Collaboration
- Support For Global Dossiers in All Regions
- Validation-Ready
|
Learn more about this solution here