Multi-Agent FDA Q-Sub Briefing Package Solver

Underwrite deploying multi-agent AI systems analyzing predicate device testing standards to draft FDA Pre-Submission briefing documents and formal questions for CDRH review divisions.

Clients & Q-Sub SOWs

Active MedTech Q-Sub Retainer Clients

Monthly Continuous Strategy Retainer ($ / client / mo)

Custom Enterprise Q-Sub Dossier Builds / Year

Average Dossier Build SOW Fee ($ - e.g. $65,000)

Annual Consulting Financials

Annual Gross MedTech AI Regulatory Billings

$860,000 / yr

Net AI Specialist Pre-Tax Take-Home Income

+$798,400 / yr (92.8% Margin)

Predictable Monthly Regulatory Retainer MRR

$50,000 / mo