News
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 […]
Agreement Signed with the State Expert Center of the Ministry of Health of Ukraine for the Pharmacovigilance System
We are pleased to announce that on January 1, 2025, the Institute for Information Systems Development and the State Enterprise “State Expert Center of the Ministry of Health of Ukraine” (SEC MoH Ukraine) signed Contract No. 1/5-25 for system support services of the Automated Pharmacovigilance Information System (AISF). The AISF system is designed to serve […]
Development of a module to support GMP processes and pass production audits
We are pleased to announce that we have completed the development of a new software module “Register of Pharmaceutical Production Equipment and Systems DSBase-PER” to support GMP processes and production audits. The DSBase-PER module, through digitalization, improves the quality of management of accounting, operation, maintenance and repair processes of production equipment and enterprise systems, allows […]