Freyr Digital
  • talk to us!

EAEU Compliant eCTD Submissions Using Freyr SUBMIT PRO

About Customer

US based Global Biopharmaceutical company with major focus on Hematology, Cardiovascular, Immunology, Fibrotic Diseases and Neuroscience based products.

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.

Freyr Solution Offered

  • User-friendly eCTD Regulatory publishing and submission software for lifecycle management, powerful search, notifications, tracking, and reporting for EAEU
  • Powerful audit trails and dashboards for submission metrics
  • Available eCTD templates/folder structures for EAEU as per the regulations
  • Integration with DMS

Implementation Timeline

  1. Demonstration

     

    Oct -19

  2. Kick-Off

     

    10500 Product Registrations

    Jun - 20

  3. User Acceptance Testing

     

    10+ Countries

    Jul - 20

  4. Go-Live

     

    185+ Users Globally

    Jul - 20

Key Benefits Delivered

Solution Advantage

  • Hassle free data entry and management with existing Freyr centralized data entry team.
  • Regulatory compliance eCTD submissions.
  • Supports all type of response submissions.
  • Validated eCTD submissions.
  • Role based users for better control over submissions.
  • Significant cost savings and leveraging existing investments.
  • One stop eCTD submission management platform.
  • Annex 11 compliant and validated system.

Platform Advantage

On-Premise and Cloud Solution:

On-Premise and Cloud based platform offering 24X7 accessibility and availability

Configurable Web- Based Solution:

Web-based solution offering dynamic feature - rich modules which are highly configurable

Flexible Integration:

Flexibility in integrating with Freyr’s Software Suite as well as with any third-party Regulatory tools using APIs

Quick Inquiry
x