Examples of services include:
- Education and consultations
- Sponsor-Investigator training
- Pre-IND submissions
- IND/IDE initial application submission and continued maintenance
- FDA Annual Reports
- FDA Amendments
- Safety Reporting
- Closeouts
*At this time, our regulatory support is tailored specifically towards interactions with the FDA. All investigators will need to work with their division to identify a research team/coordinator for study oversight, protocol preparation, and IRB approval/maintenance.
Contact:
Kristen Herzegh, MPH, RAC
Senior Regulatory Specialist
