xFDA Investigators was established in 2004 by Dusty Snoeberg-Renwick, a former FDA pharmaceutical and medical device investigator, to provide FDA-regulated organizations with quality and compliance support grounded in direct Agency experience.
Over two decades the firm has supported pharmaceutical, biotechnology, medical device, diagnostics, laboratory and clinical research organizations with quality systems, manufacturing and development compliance, validation, laboratory compliance and remediation work.
The firm's approach has remained consistent: help organizations understand what regulators actually require, and build systems that are practical enough for employees to follow and sustain.