Regulatory Affairs

The Regulatory Affairs division of the Office of Research Compliance provides a variety of services to support FDA regulated research. The following services are available:

  • Clinical Research Monitoring ServicesFee-for service monitoring is available for investigators that hold an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) with the FDA. Services are offered for single or multi-site studies and fees are structured based on proposed number of sites and subjects enrolled.
  • IND/IDE Services and Resources

Regulatory Affairs Team

Director: Emmelyn Kim, MA, MPH, CCRA, CHRC
Clinical Research Monitor: Sharon Hochman, MA
Research Pharmacist: Ji-Eun Kim, RPh, PhD