AI tools for CMC and regulatory work
I made seven tools for CMC and regulatory work. Each one started as a problem that I saw on programs. Each page shows the problem, what the tool does, how it stays inside the rules, and a demo.
None of the tools makes a GMP decision. The draft EU GMP Annex 22 says that regulated companies should not use generative AI in critical GMP applications, such as batch release. For this reason, every tool keeps a named person as the decision-maker. AI in CMC: what regulators allow →
Module 3 Authoring Tool
Drafts Module 3 sections from source documents and cites every sentence to the table or section it came from.
Open the demo →BridgeOS
One workspace for the full chain: route plan, evidence, cited drafts, submission pack, and change impact.
Open the demo →CMC Decision Platform
A concept design that puts CMC, clinical, and regulatory inputs into one decision memo with an audit trail.
Open the demo →CMC Risk Engine
Finds schedule and dependency risk before the governance report shows it.
Open the demo →CMC Portfolio Control
Makes one leadership view of the portfolio from the schedules and trackers that teams already use.
Open the demo →CMC Program Dashboard
Shows the same program status in three views: for leadership, for the PM, and for each CDMO.
Open the demo →CMC Knowledge System
Makes templates and checklists from the lessons of past submissions and audits.
Open the demo →