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 medicinal products during variations and re-registration.
eCTD RIMS fully complies with ICH electronic Common Technical Document (eCTD v3.2.2) requirements, while Module 1 specifications align with Order No. 691 of the Ministry of Health of Ukraine (April 23, 2024), incorporating all updates.
Key Features and Capabilities:
- Intuitive interface and user-friendly design for simplified dossier submission
- Full compliance with Ukrainian eCTD requirements
- Support for certified Ukrainian electronic digital signatures (QES)
- Pre-submission dossier validation for the State Expert Center of the Ministry of Health of Ukraine
- Automated envelope generation for submission to the State Expert Center
- Electronic logs for tracking and managing regulatory authority feedback
- Tools for file import and document uploads
- Ability to create additional branches within the eCTD structure
- Comprehensive tracking of registration dossier records
- Integration with the company’s medicinal product registry in the DSBase database
And much more!
The software is now available for order and integration. Our experts provide comprehensive training, technical support, and system customization to meet the individual needs of our clients.
For more detailed information, please visit the eCTD RIMS page on our website or contact us directly.
The launch of this new eCTD software opens new opportunities for pharmaceutical companies, simplifying regulatory processes and enhancing operational efficiency. We are confident that eCTD RIMS will become a reliable tool for your regulatory workflows!
Other News
Сompletion of the development of the new Digital Medical Device Quality System eMDD-RIMS
We announce the completion of the development of the new Digital Medical Device Quality System eMDD-RIMS. eMDD-RIMS is a document management system for manufacturers, authorized representatives and distributors of medical devices that significantly simplifies the management of regulatory and quality documentation. The system allows you to create a centralized documentation repository with access for all […]
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 […]