service

Regulatory Knowledge & Support

Price: Various rates; see attached

Expert support for faculty with new grants, small business innovative research grants, and start-up companies

University of Southern California (USC)
Children's Hospital Los Angeles (CHLA)
Goal: Receive Guidance on Regulatory Processes
Phase: Design A Study
Phase: Find and Secure Funding
Phase: Get IRB Approval

Service description

The SC CTSI team provides support for faculty with new grants, small business innovative research grants, and start-up companies. This may include but is not limited to investigational new drug (IND) applications, investigational device exemptions (IDE), internal monitoring and auditing, meeting requests and briefing packages, dietary supplements marketing strategies, and marketing applications for drugs and devices. 


Benefits for users

The SC CTSI team supports strategic planning from design to market and provides advice and services for compliance.  

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Cost

Complimentary first hour service*.
USC faculty: $150/hour after initial consultation.
USC Student/Associate Support: $60/hour after initial consultation. More information is available here.
*Fees for regulatory expertise may be built into a research grant.


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.