service

Regulatory Knowledge and Support Translational Consultation Center

Supports faculty with regulatory guidance for INDs, IDEs, audits, and FDA submissions for clinical and translational research.

Goal: Develop a Regulatory Strategy
Goal: Understand Monitoring and Auditing
Goal: Impact Regulations and Policy
Phase: Planning & Design
Phase: Study Operations
Phase: Close-Out & Beyond

Who we serve

  • Faculty with new grants
  • Small business innovative research grants
  • Start-up companies

We can assist with

  • Investigational drug (IND) applications
  • Investigational device exemptions (IDE)
  • Internal monitoring & auditing
  • Meeting requests & briefing packages
  • Dietary supplements marketing strategies
  • Marketing applications for drugs & devices

Request this service

Click here

Contact information

Karen Manrique, MS
Project Administrator, Regulatory Knowledge Support

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NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.

This program is open to all eligible individuals. SC CTSI operates all of its programs and activities consistent with the University’s Notice of Non-Discrimination. Eligibility is not determined based on race, sex, ethnicity, sexual orientation, or any other prohibited factor.

For our complete Terms of Use, including privacy and legal compliance statements, click HERE.  Copyright © 2026 SC CTSI: Southern California Clinical and Translational Science Institute at USC and CHLA. All rights reserved.