About us
iRIS Soft (ІРІС, Інститут Розробки Інформаційних Систем) is a leading Ukrainian company in the IT industry. Since 2015, we have been implementing innovative technological solutions for the pharmaceutical sector and government institutions both in Ukraine and abroad. Our web solutions and digital platforms help businesses enhance productivity, efficiency, and transparency.
We specialize in developing software for regulatory compliance, pharmacovigilance, business process management and automation, as well as data and document management.
Key Software Products:
- eCTD RIMS – Solution for creating and submitting regulatory dossiers in eCTD format.
- DSBase – A platform for managing pharmacovigilance activities.
- eGMP/GDP – A system designed for quality departments of manufacturers, importers, and warehouses.
- Germes PV – Automation tool for searching reports on adverse reactions.
- eMDD RIMS – Regulatory document management system for medical devices.
We continuously monitor changes in regulatory requirements, implement the best software solutions to meet them, and regularly update our products. Additionally, we provide professional technical support to our clients in Ukrainian.
Our undeniable advantages include customer-centricity, deep knowledge of regulatory requirements, rapid implementation of innovations, and a highly efficient support service. Our clients benefit from prompt consultations, user training, and continuous feedback, ensuring the stability and ease of use of our products.
Our team comprises over 30 highly qualified professionals with extensive experience in IT consulting and software development, combined with expertise in the pharmaceutical and medical industries.
We offer not only ready-to-use products but also custom software development “from scratch,” tailored to the client’s business processes. This includes integration, validation, and technical support to meet your specific needs.
Our achievements
iRIS is the developer of key national information systems, including the Automated Information System for Pharmacovigilance (AISP) for the State Expert Center of the Ministry of Health of Ukraine, which integrates over 2,000 medical institutions and 800 pharmaceutical companies. We also developed the “Technical Regulations” system for the Ministry of Economy of Ukraine, facilitating seamless collaboration with more than 160 conformity assessment bodies in the field of technical regulation.
To date, we have successfully completed over 80 projects for esteemed clients such as the Verkhovna Rada of Ukraine, Kyiv City State Administration, the National University of Pharmacy, Acino Group (Switzerland), Pharma Start, Yuria-Pharm, Lekhim PJSC, Kusum Group (India), and many others.
We currently collaborate with more than 25 pharmaceutical companies across Ukraine, Switzerland, India, Kazakhstan, Uzbekistan, Moldova, and other countries, providing them with cutting-edge digital solutions.
iRIS is a trusted partner of Microsoft (USA), MicroStrategy (USA), and Gordic (Czech Republic), reflecting our high level of professionalism and the confidence of global technology leaders.
Our products and services are used by:
Information Security
iRIS software solutions provide reliable information protection through advanced access management systems, user privilege allocation, action logging, and auditing. All data and documents are safeguarded against any unauthorized interference, adhering to modern information security standards.
With a centralized data and document repository, users benefit from controlled and convenient access to information that is both fast and secure. A unified database management system and a robust backup service ensure the reliability of document storage, eliminating the need for users to create their own copies of confidential information.
Advantages of iRIS Software Solutions
iRIS solutions stand out for their ease of implementation, flexibility in configuration, and adaptability, making them suitable for companies of any scale. With a phased deployment approach, you can start by automating critical processes and gradually scaling the system across your entire organization.
Our solutions become operational almost immediately after quick installation and setup, delivering high efficiency and rapid return on investment. There is no need for prior business process reorganization or extensive user preparation—basic experience in your field is sufficient to get started.
iRIS software solutions are designed with a focus on continuous development, the addition of new features, and maximum user convenience. We are always open to customer feedback and requests, which often form the foundation for our future innovations.
Original technologies
iRIS software solutions cover a wide range of functionalities essential for modern businesses, including data management, document workflow automation, and reporting. With a modular architecture, our products are flexibly tailored to meet the needs of businesses of all sizes—from small enterprises to large corporations.
Our solutions are highly scalable, supporting up to 1,000 concurrent users and designed to handle large data volumes and complex business processes. We continuously update and enhance our products to ensure every client maximizes the benefits of tried-and-tested solutions and industry best practices.
Our Services
iRIS provides comprehensive services for building and maintaining digital information systems, including:
- Analysis of the client’s existing information infrastructure.
- Development of the architecture and concept for the future system.
- Creation and approval of technical specifications.
- System development and configuration based on iRIS’s standard software solutions.
- Initial data loading for a quick start.
- Preparation of project and operational documentation.
- System validation and implementation.
- Integration with the client’s existing systems.
- User training, technical support, and consultations.
- System maintenance, warranty services, hosting, and cloud solutions.
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 […]