Q BRIDGE AI runs two AI-first FDA submission platforms — DeviceBridge (FDA 510(k) for devices, CDRH) and INDBridge (FDA IND for drugs and biologics, CDER + CBER). Specialist Claude agents draft every artifact, named regulatory leads e-sign at nine human gates, and a tamper-evident audit chain records every action. Hosted on AWS healthcare-grade with HIPAA BAA Day 1. Built for 21 CFR Part 11. Validated to GAMP-5 Category 5.