eCTDlight

eCTDlight is a browser-based tool developed by DrugCard for preparing and submitting medicinal product registration dossiers in eCTD format to Ukraine's State Expert Center. It is designed for pharmaceutical companies that need to comply with Ukraine's 2025 eCTD submission requirements without investing in expensive software licenses or undergoing complex system training.

DrugCard is a Ukrainian company that has been supporting pharmaceutical companies with pharmacovigilance automation since 2021, with users across more than 121 countries. eCTDlight extends that work into the regulatory submission space, focusing specifically on the Ukrainian market and its updated 2025 standards.

Key Capabilities

• Creation of eCTD dossier structure compliant with Ukraine's 2025 requirements
• Automatic XML generation
• Module 1 support tailored for Ukraine
• Archive building for submission to the State Expert Center
• Ukrainian language support

Deployment and Access

• Runs entirely in a web browser — no installation required
• No software license purchase required
• Simple web-based interface intended to reduce the need for complex training

Intended Users

• Pharmaceutical companies submitting medicinal product registrations in Ukraine
• Regulatory affairs teams that need to meet the mandatory 2025 eCTD format requirements without large infrastructure investments

eCTDlight is positioned as a focused, low-barrier entry point for Ukrainian eCTD submissions, covering the core workflow from dossier structuring through archive preparation. DrugCard offers special terms for early adopters of the service.