A 30-person firm uses AI to prepare FDA filings, but one hallucination could cost a client a year
alex_verem · x · 2026-07-25
A private-equity-backed regulatory services firm uses an AI system to read and classify thousands of documents for FDA submissions.
- The COO says the bar is absolute: if the system hallucinates or misclassifies a compound, the submission can fail and the client may lose a year.
- The firm has about 30 people and no IT department.
- A founding partner built the system, then retired without documentation or a successor.
- The models were still running on software that was two to three years old, with almost no oversight, and even the AWS account holding the whole stack had become a risk.
The post is less about a product launch and more about the operational fragility of mission-critical AI inside a regulated business.
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