Submitting eCTDs & NeeS?

Electronic submissions are currently accepted in 32 countries in North America, Europe, and Asia.

An enormous challenge facing today´s submission specialist is the changing regulatory landscape for submissions in paper or in electronic format. As standards evolve, publishers must adapt. Add in the complexity of submitting globally - where requirements differ from region to region - and that challenge increases dramatically. The third generation of the LORENZ eValidator not only includes all available eCTD criteria from European EMEA and Japanese PMDA, Health Canada, US FDA and Switzerlands Swissmedic, but also the ability to validate NeeS submissions.

Reduce your risk with the LORENZ eValidator for both eCTD and NeeS validation.

• Quickly adapt to changing regulatory requirements
• Support submissions for all ICH eCTD regions
• Generate detailed reports on PDF & submission-readiness
• Perform deep lifecycle analysis
• Multi-language interface
• The LORENZ eValidator comes in two versions: a basic version, available freely for download, and a professional pay version
• The following agencies also use or recommend the LORENZ eValidator:
• Austria: Austrian Agency for Health and Food Safety
• Canada: Health Canada
• Germany: Federal Institute for Drugs and Medical Devices
• Poland: Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Slovenia: Ministry of Health
• Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Switzerland: Swissmedic
• LORENZ DOES NOT force users of the LORENZ eValidator in automatically becoming a LORENZ reference customer.