Health Authority Query Response demo
An inbox for agency letters: each question arrives with a cited draft reply, an owner and the clock, plus a check of what every other agency was told. 1:14
What the demo shows
A regulatory affairs solution for submission teams that drafts answers to regulator questions.
Splits each agency letter into its questions, drafts a reply to each from the dossier and approved past answers with a citation for every number, routes it to its owner, counts down the agency clock, and compares every number with what every other agency has been told before the regulatory lead signs.
Transcript
- Health Authority Query Response drafts answers to regulator questions for regulatory teams.
- Seven agencies ask about one product and the answers drift.
- An FDA information request lands, 12 questions, 10 days.
- One click splits it, assigns owners, and drafts a cited reply to each question.
- Beside each reply, what every other agency was told.
- Question 7 flags it.
- Health Canada was told 4.6% from an earlier cut.
- One click adds a data cut note, so both numbers are explained.
- The grid shows every fact told to every agency and catches the Swiss medic shelf life.
- cited first drafts within hours owners review and the regulatory lead signs built on Botminds agents, data, screens and governance on one platform
Transcribed from the film’s narration. Captions are on the player.