CTD/Paper Submission

Nowadays, Regulatory Agencies across the globe apart from accepting regulatory documents electronically also accept paper submissions. Therein, KnowledgeNET provides tools for simple, quick and instinctive construction of complex, valid non-electronic CTD submissions as well as paper submissions prepared for Canadian, EU, Japanese, Swiss and US regulatory agencies.

KnowledgeNET NeeS electronic submissions (EU) and Paper CTD submissions comply fully with the folder and file organization as presented in the ICH eCTD specification document. KnowledgeNET provides submission-related document templates, as well as pre-configured document types specific to a company's submission.

KnowledgeNET CTD/Nees provides:

• An easy-to-use intuitive user interface
• Spontaneous access buttons for frequently used tasks such as submission validation, publishing and more...
• Full support for submission of EU NeeS, CTD henceforth tackling with Centralized, National, Decentralized and Mutual Recognition procedure submissions
• Also supports paper-, hybrid- submissions for Canada, US and other countries
• Facility of HTML publishing the dossier in CTD format for non-regulated markets (i.e., countries in South America, Africa, etc.)