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eCTD RIMS (Regulatory Information Management System) is a comprehensive system for creating, submitting (publishing), and managing the lifecycle of pharmaceutical product registrations, including amendments and re-registrations.

The system complies with the requirements of ICH electronic Common Technical Document (eCTD) v3.2.2 and meets the Module 1 Specification outlined in the Order of the Ministry of Health of Ukraine No. 691, dated April 23, 2024, with all subsequent amendments.

Key features:

• Generate regulatory dossiers in eCTD format for new registrations, renewals, variations, or baseline submissions in accordance with Ukrainian requirements; 
• Validation: ensure dossier accuracy and compliance before submission.
• Lifecycle management: manage the entire lifecycle of a dossier, including updates and re-submissions.
• Change comparison: analyze and track changes between dossier versions. 
• Import and export: seamlessly import and export dossiers to streamline workflows.
• Automatic file renaming: automatically update file names to maintain consistency with eCTD requirements.

Additionally, upon request, testing for EU and EAEU (NeeS format) submissions is available.

DSBase (Drug Safety Base) is a powerful information and analytical tool designed for applicants and manufacturers to ensure compliance with Good Pharmacovigilance Practice (GVP) standards and automate all key processes related to drug safety monitoring.

The platform is tailored for maintaining registration information, monitoring safety, and generating and submitting pharmacovigilance reports, enabling companies to efficiently meet their obligations to regulators and patients, pass pharmacovigilance audits, and manage safety information effectively.

DSBase automates the recording, analysis, and evaluation of adverse reactions and lack of efficacy data for medicinal products, creating a reliable electronic documentation system. This system supports the control, recording, and management of all aspects of pharmacovigilance that may directly or indirectly affect product quality. It is an integral part of the quality assurance system and plays a key role in the operations of a pharmaceutical company, helping to meet international standards for quality and safety.

eGMP/GDP Electronic Document Management System is an innovative solution for automating document management for manufacturers, importers, or distributors of medicinal products. It is designed to optimize business processes, enhance operational efficiency, and ensure compliance with regulatory requirements, including GMP and GDP standards.

Modules for equipment and facility registers, pharmaceutical production/warehouse systems, task execution monitoring, and KPI assessment enable effective management and planning of the pharmaceutical quality system in a digital format.

The system adheres to all requirements for electronic document management, supporting qualified electronic signatures (QES) and ensuring compliance with 21 CFR Part 11.

Germes PV is a web-based platform designed for automated monitoring of periodicals and online resources (websites, web portals, electronic libraries, etc.) to identify publications, particularly those related to the safety of medicinal products.

The platform offers features such as search planning based on trade names or international nonproprietary names, regular monitoring of periodicals and online resources, downloading full-text publications and hyperlinks for storage in a database, logging search results, and generating monitoring reports.

Germes can be provided as a standalone product or as part of the DSBase platform.

eMDD RIMS is an electronic document management system designed to digitize and significantly simplify the management of regulatory and quality documentation for medical devices.

The system enables the creation of a centralized documentation repository accessible to all employees. Through this platform, users can develop, create, manage document versions, and electronically sign documents, as well as set and monitor task deadlines, conduct training, and more. By streamlining these processes, eMDD RIMS enhances efficiency, ensures compliance with regulatory requirements, and provides a robust framework for managing the complete lifecycle of regulatory and quality documentation.