Regulatory and FDA Support

The Regulatory & FDA Support Core are a team of dedicated support staff who are well versed in the regulatory approval and startup processes of the FDA and the Institutional Review Board (IRB). As a fee for service team, the FDA & Regulatory Support Core can provide flexible services based on the individual needs of each department/investigator and can begin at any point in the research trial.

Upon request, services from the core can begin immediately and be maintained on a short- or long-term basis. In addition, the FDA & Regulatory Support Core are available to provide consultation services prior to the start of a clinical trial to assist investigators with drug/device/biologic pre-clinical questions, biostatical support, and guidance on the correct regulatory pathway with the FDA and IRB.

FDA support services include:

  • Protocol review and evaluation
  • Drug and device risk determination
  • IND/IDE application assistance
  • Regulatory document/binder creation
  • Source document creation
  • FDA regulatory monitoring
  • Long term FDA maintenance
  • Biostatistician support

Regulatory support services:

  • IRB application and study start-up support
  • Regulatory document/binder creation
  • Investigator and study team education/training
  • Regulatory prep/clean-up for monitoring visits
  • Long-term regulatory maintenance
  • Study closure support

To request service, please complete this form:

Regulatory/FDA Guidance Core Work Request Form

For additional information, email our Central Inbox at or contact Jenna Arlow, Manager, Regulatory & FDA Support Core at or at 216-286-0754.