We are developers of specialized software for the pharmaceutical and medical industries.
We offer digital solutions for:
Registration
A simple solution for generating a registration dossier in the e-CTD document format, in accordance with the Ukrainian specification of Module 1, accompanied by the necessary training and support.
The program provides generation, validation and submission of a registration dossier in the e-CTD format, entering the sequence of submissions in the chronology of events, life cycle management β responses to comments, changes and re-registration. A single tool for working in many markets: EAEU and EU (in development).
Pharmacovigilance
A pharmacovigilance platform for a company or group of applicants that covers all critical processes according to GVP requirements and allows for rapid scaling: from the tasks of a local contact person (ULOF, KLOF) to a system covering dozens of countries.
A single database provides for maintaining a register of medicinal products, collection and processing of adverse reaction reports, electronic data exchange in ICH E2B (R2)/(R3) formats, development of a pharmacovigilance quality system, signal management, support for monitoring literature and Internet sources.
Production, warehouse
A key tool for digitalizing the quality management system and document flow in production or warehouse according to GMP and GDP requirements, facility management and equipment technical condition control (technical supervision, verification, calibration, etc.).
The system includes technologies for mass digitization of paper documents, QR-marking of documents, facilities and equipment, supports QEP and compliance with 21 CFR Part 11.
Our software is built on a unified platform with a modular system
Our products and services are used by:
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 β 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 […]