News
eCTD in Ukraine: A New Format for Registration Dossiers and Practical Aspects of Implementation
On August 18, a landmark event took place in the regulatory sphere: Ukraine officially transitioned to the electronic Common Technical Document (eCTD) format. From this date forward, registration dossiers for new marketing authorizations must be submitted exclusively in electronic format, with the exception of procedures regulated by Orders of the Ministry of Health of Ukraine […]
iRIS Soft Participates in the “PHARMEXPERT 2025” Forum
The iRIS Soft team actively participated in the “PHARMEXPERT 2025: eCTD and Pricing in Ukraine — A Strategic Path to Integration into the International Regulatory Environment” forum, held on June 17, 2025, in Kyiv. During the event, the company presented its own innovative solution — the Electronic Dossier Management System eCTD-RIMS. iRIS Soft representatives joined […]
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 […]