Business Need

The goal was to implement a system that can create EAEU eCTD compliant submissions.

• An electronic system to compile, validate, publish, track and manage the dossiers in eCTD format for the EAEU region.
• Tracking lifecycle management and submissions variations.
• Support in understanding the developing changing regulations and altering Regulatory standards.

Key Objectives

To compile, validate, and publish EAEU Regulatory submissions efficiently based on decisions and rules set by different Health Agencies

• Supports current eCTD folder structure and XML format
• Allows validation for an expanded variety of application types like Original, Generic, Hybrid, Biosimilar, Vaccines, etc.
• Provides intuitive dashboard and reporting capabilities
• Integrates with Electronic Document  Management System (EDMS)
• User-friendly life cycle management with powerful audit trails

Scope

• A robust and an user-friendly eCTD submission platform with EAEU Regulatory compliant folder structure and XML backbone.  
• Compile, validate, publish, track, and manage dossiers for all the existing submissions.