ZAI manages and operates FDA’s Document Control Rooms (DCRs) for the Centers for Drug Evaluation and Research, Veterinary Medicine, Tobacco, and Devices and Radiological Health.The DCRs are lifecycle case file management centers that receive, validate, process, and store drug applications, regulatory submissions, clinical trials, correspondence, and other pharmaceutical case records used to evaluate the safety, efficacy, and security of human and veterinary drugs and medical devices. The DCRs operate in a highly visible, fast-paced, multi-faceted, production-oriented environment that directly supports FDA’s mission.

We continually work with the FDA to identify, design, develop, and deploy new methods for reducing costs and increasing records management efficiency. During the more than 20 years ZAI has provided information management and technology services to FDA, we’ve been awarded more than 200 FDA task orders.