News
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 […]
New Release of the Electronic Dossier Management System eCTD-RIMS
iRIS Soft has completed the development of a new release of the Electronic Dossier Management System eCTD-RIMS. The new version incorporates user suggestions for improving system efficiency, as well as experience accumulated during system operation and submission of eCTD documents to the Applicant’s Cabinet of the State Expert Center of the Ministry of Health of […]
Webinar on the Implementation of eCTD in Ukraine: Key Changes and Technical Aspects
On April 2, 2025, iRIS Soft successfully conducted a training webinar dedicated to the implementation of the electronic Common Technical Document (eCTD) in Ukraine — a modern format for regulatory dossier submission aligned with ICH international standards. The event was held in the context of preparations for the mandatory transition to eCTD, which will come […]
IRIS Soft Celebrates Its 10th Anniversary!
This year, our company IRIS Soft (Institute for Information Systems Development) is celebrating 10 years of its activity! Ten years of dedicated work, innovation, and achievements that have established us as a leader in the field of information systems development for the pharmaceutical industry. Over this time, IRIS Soft has become a trusted partner for […]
The preparation of the electronic Common Technical Document (eCTD) format
The preparation of the electronic Common Technical Document (eCTD) format for drug registration requires pharmaceutical companies to transition from paper-based documentation to digital management, review established business processes, and reformat existing regulatory dossiers to comply with the new electronic standard. This transition leads to an increase in the number of files that make up the […]
Launch of eCTD RIMS: Ensuring Compliance with Digital Transition Requirements
We are pleased to announce the expansion of our software portfolio with the launch of eCTD RIMS, a Regulatory Information Management System designed for the creation, validation, and submission of registration dossiers in eCTD format to the State Expert Center of the Ministry of Health of Ukraine. The system also facilitates the lifecycle management of […]