Electronic record and document content management system with electronic submission to regulatory agencies (eCTD).

Since 1990, ICH (International Conference on Harmonization) has been working to create a standardized framework for drug and biological product registration. An expert working group within ICH is working on the eCTD (electronic control technical document) specification, an electronic equivalent to paper CTD. An eCTD is primarily a specification for interfacing between the regulatory agency and the industry to enable the transfer of regulatory information while at the same time facilitating the initiation, creation, review, lifecycle management, and archival of the electronic submission.

eCDT Solution from SoluSoft
The eCDT Solution from SoluSoft solution helps Pharmaceuticals companies to create, update, store, and publish the complete set of dossier documents and manage, compile, review, register and archive eCTD submissions to regulatory agencies like US FDA and UK MHRA.

Business Objectives

The business objectives are as follows:

• Provide streamlined eCTD process system that deals with complete life cycle of eCTD submission from initiation through reviewing, verification, recording, approving, and completion
• Provide eCTD process implementation per ICH eCTD compliance
• Provide eCTD submission output format that is expected by regulatory agencies
• Utilize a single tool instead of multiple disparate tools to process eCTD using task assignment, deadline, alerts, escalation, scheduling, collaboration, discussion, routing, and version control
• Provide an audit trail to record activity at every step
• Provide validation and process reports

Business Value

• The business values are as follows:Eliminate or minimize regulatory risks and process delays
• Increase in credibility due to regulatory compliance
• Structured and unstructured information is organized and managed
• Enforces best practices for eCTD submission