Insights
Practical notes on regulatory AI.
2026-10-28 · 3 min
Regulators now review with AI. Is your filing ready?
The FDA has its own AI tool. Here is what that changes for how you prepare a submission.
Read →2026-10-30 · 3 minWhat an IND gap assessment catches, and why to run one before you file
Missing content, inconsistent statements and unsupported claims are cheaper to fix before submission.
Read →2026-11-03 · 3 minSource tracing: why every AI-drafted statement needs a link back
In regulated work, an answer you cannot trace is an answer you cannot use.
Read →Ready when you areKnow where you stand
Know where you stand
before you build.
Tell us about your AI initiative or your next filing. We will tell you what a scoped engagement would cover and how it would be priced.