Building an eCTD sequence in DnXT Publisher, step by step, and the design choices that move validation from the last night to the first draft.
After you fix a sequence and validate it again, the question is not “how many findings are there?” It is “did my changes fix what they were meant to — and add nothing new?”
Every outsourced sequence depends on the sponsor confirming what goes in it. Too often that confirmation is an email thread and a spreadsheet the publisher re-keys by hand.
Every agency request your programme has received, and every response you filed, is already in your submissions. The hard part is reading it back — word for word, with the answer beside it.
Which documents are currently in force in a given CTD section, across every sequence you have filed? The answer exists in your submissions. In most systems it is not in a form anything can query.
Most ‘AI search’ in regulatory software is keyword matching with a chat interface. Here is what true vector retrieval looks like, why citations are non-negotiable in GxP, and how we proved ours works.
DnXT’s auto-assign engine places documents into eCTD sections using patterns mined from 3,081 real sequences — deterministic first, AI last, and every placement explainable.
We studied 14 real NDA-program tracking spreadsheets before building DnXT’s document tracking grid. Here is what Excel gets right, where it breaks, and what replaces it.
How DnXT models multi-market submissions: a global core template, market variants that inherit and diverge deliberately, and a variance ledger that shows every difference at a glance.
DnXT’s Predictive HAQ Readiness forecasts the health authority questions your submission is most likely to receive — before you submit — grounded in analysis of 1,000+ real agency questions.
