Who We Are


Wake Forest School of Medicine

The IND/IDE Navigator in the Clinical and Translational Science Institute (CTSI) was established to provide regulatory support, guidance, and education services to faculty investigators involved in US Food and Drug Administration (FDA) regulated clinical research at Wake Forest School of Medicine.
Our primary focus is regulatory assistance to clinical sponsor-investigators planning to utilize either a drug or biological product classified by the FDA as an Investigational New Drug (IND) per 21 CFR Part 312 or a medical device subject to Investigational Device Exemption (IDE) regulations per 21 CFR Part 812. Our efforts help ensure clinical research excellence and regulatory compliance as set forth by Wake Forest School of Medicine and the FDA.

CTSI Regulatory Guidance
wakereg@wakehealth.edu
https://ctsi.wakehealth.edu/regulatory-guidance

Who We Are