New Release: eCTD-RIMS Version 4.0 with Enhanced Functionality and Intelligent Assistant eCTD-AI

On June 10, 2025, iRIS Soft officially launched version 4.0 of its flagship software — the Electronic Dossier Management System eCTD-RIMS. The update brings a series of significant enhancements and new modules that substantially extend the system’s capabilities for applicants submitting electronic Common Technical Documents (eCTD).

Key Updates in eCTD-RIMS Version 4.0:

• eCTD-Manager – for creating, maintaining, and generating dossiers in eCTD format
• eCTD-Validator – for validating eCTD documentation
• eCTD-Product – for managing medicinal product registration data
• eCTD-Sign – for digitally signing documents using Qualified Electronic Signature (QES) in compliance with Ukrainian legislation
• eCTD-Reports – for generating print-ready reference and reporting forms
• eCTD Intelligent Assistant (eCTD-AI) – an intelligent module supporting eCTD documentation preparation
• Additional integrated services:
• Submission Tracking Table Generator
• Regulatory Comment Journal and Response Tracker
• eCTD-Splitter – for dividing consolidated M1–M5 DOC files into individually formatted documents

Full Integration with the eCTD-Base Repository
The new release is fully integrated with the eCTD-Base Document Repository, a file management system designed to centrally manage all document versions in DOC and PDF formats throughout the regulatory dossier lifecycle.

Key features of eCTD-Base:

• Version control and relevance monitoring of documents
• Document change history tracking
• Support for collaborative document preparation
• Document preview, full-text search, and version comparison
• Convenient file import from external storage

Smart Guidance with the eCTD-AI Module
The eCTD Intelligent Assistant (eCTD-AI) significantly simplifies and accelerates the preparation of regulatory documentation. It automates routine actions, ensures structural compliance with eCTD specifications, helps eliminate errors, and improves efficiency and accuracy.

eCTD-AI functionality includes:

• Automated file name coding according to ICH and Ukrainian regulatory standards
• Cyrillic-to-Latin file name transliteration
• Format and file size validation
• Input data and dossier structure validation in line with Module 1 requirements (per MOH Order No. 691)

Compliance with Regulatory Standards
eCTD-RIMS Version 4.0 is fully aligned with the Order of the Ministry of Health of Ukraine No. 691 dated April 23, 2024, as amended. This order establishes mandatory structure and format requirements for Module 1 of the UA eCTD and defines validation criteria for eCTD documentation.

The eCTD-RIMS v4.0 system is a robust tool for the digital transformation of regulatory workflows. It enables the full lifecycle of dossier creation, validation, and submission via the DEC Applicant’s Portal. iRIS Soft remains committed to delivering innovative, user-friendly solutions that meet both national and international standards in pharmaceutical regulatory affairs.

Keywords: eCTD, eCTD-RIMS, eCTD-AI, Intelligent Assistant, eCTD-Base Repository, DEC Applicant Portal, regulatory dossier, medicinal product registration, Ministry of Health of Ukraine, Order No. 691.