CMC Module 3 Authoring demo
Module 3 drafted from development reports, and every limit cross-checked against batches, stability, process and the summary before the dossier is assembled. 1:11
What the demo shows
A CMC regulatory writing solution for CMC teams that drafts Module 3 from development reports.
Six agents read the sources, extract every value with its page, draft each section from the closest approved wording and check every number. The Consistency checker re-runs the Module 3 cross-check on each new stability report or specification version and proposes options for every contradiction; the regulatory CMC lead decides, and limit changes go through change control.
Transcript
- CMC Module 3 Authoring drafts the quality module of a drug application for regulatory CMC teams.
- Three and four FDA complete response letters cite quality or manufacturing.
- Each limit is a row, checked against batches, stability, process and summary.
- A new stability report arrived, so Maya re-runs the cross-check.
- One row turns red.
- The assay limit is 95%.
- percent, yet two registration batches read 94.6.
- Maya picks separate release and shelf life limits and sends them for approval.
- Approved, for sections updated, and the row turns green.
- Module 3 drafted in about half the time, every number checked.
- Build on Botminds, agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.