Locate
Source content lookup
Find the exact source paragraph, study report, or prior submission section a dossier module needs to reference.
Pharma — Regulatory Dossier Support
Assemble Dossier Content in Hours, Not the Week It Usually Takes.
FortiqAI locates, compares, and assembles source content across CTD modules and change histories in plain language — with citations to the exact document and version, for your regulatory affairs team to review and finalize.
01
The source content exists. Assembling it is the bottleneck.
A dossier section rarely requires new writing — it requires finding the right source content across CTD modules, prior submissions, and years of change history, then confirming it's still current. That search is where regulatory affairs teams lose days. FortiqAI turns it into a question you can ask directly.
02
What it does.
Compare
Change history comparison
See what changed between this submission cycle and the last, with citations to both versions.
Verify
Cited, source-grounded answers
Every answer links back to the exact document and page, so your regulatory affairs team verifies it before it goes into the dossier.
03
Example questions your team can ask.
“Where is the source content for the stability data referenced in Module 3?”
“What changed in our manufacturing process description since the last submission?”
“Find every prior submission section that references this excipient.”
Pharma AI
Book a Pharma Pilot.
A scoped, fixed-price pilot on one dossier or submission cycle — see it working on your own documents.