Investigator New Drug (IND)/Investigational Device Exemptions (IDE)

The CTSI offers regulatory support and assistance navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Registrations and support services are provided by our IND/IDE Navigator, Issis Kelly Pumarol, MD. 

Available services include:

  • Providing a centralized resource of information and support related to addressing regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies under investigator-sponsored INDs and IDEs
  • Assisting WFBMC researchers in the preparation or review of initial IND or IDE applications, annual progress reports and preparing responses to the FDA

Request a Consultation 

To request a IND/IDE consultation, please use the CTSI Service Request Form. For questions, contact Dr. Issis Kelly Pumarol at or 336-716-8372.

IND Forms and Instructions

Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD)

Regulatory Guidance of Academic Research of Drugs and DevicesThe Regulatory Guidance for Academic Research of Drugs and Devices (ReGARDD) affiliates are comprised of regulatory affairs specialists and experts from North Carolina Institutions that receive funding from the NIH Clinical and Translational Science Awards (CTSA) Program. Currently these institutions are the University of North Carolina at Chapel Hill, Duke University, Wake Forest School of Medicine and RTI International.