Post-Marketing Commitment Tracking demo
Every PMR, PMC, EU obligation and promise on one timeline by product, each date linked to the letter or minutes page it came from, including promises made outside approval letters. 1:13
What the demo shows
A regulatory compliance solution for regulatory affairs that tracks post-marketing commitments.
Agents read every approval letter, set of minutes and response and put each requirement, commitment and promise on one timeline by product, with the agency's exact words and the page. A Promise Finder re-reads minutes and responses, discussion included, and catches promises nobody tracked. A deadline monitor alerts owners from 90 days out and a reporter drafts the annual status tables. The regulatory lead signs every entry.
Transcript
- Post-Marketing Commitment Tracking puts every promise a drug company owes its regulators on one timeline for regulatory affairs.
- The hard ones are not in approval letters.
- They hide in meeting minutes where nobody tracks them.
- Northwind Bio owes 29.
- Each date links to the page it came from.
- Omar reads three new FDA letters.
- The new dates appear, dashed until he signs.
- A new pediatric Crohn's study arrives.
- Its protocol is due in nine months.
- A new approval makes the promise finder re-read Veltrimab's minutes on file.
- It finds a promise from a Type-C meeting in May.
- Shipping validation. Due March 31st, never tracked.
- Omar signs it onto the timeline.
- Lina owns it, and she will hear 90 days ahead.
- Built on Botminds: agents, data, screens, and governance on one platform.
Transcribed from the film’s narration. Captions are on the player.