Regulatory Knowledge & Support

RKS helps move USC and CHLA discoveries from research to commercialization. Because of the long timeline, heavy resource burden, and high regulatory hurdle of bringing new products to market, RKS works closely with investigators to identify critical steps in the go/no-go decision-making process. The team has assisted with Small Business Innovative Research (SBIR) and other grants; regulatory agency meeting requests and briefing packages; filings for investigational new drugs (INDs), investigational device exemptions (IDEs), dietary supplements, and combination products; abbreviated new drug applications (ANDAs); marketing submissions; monitoring and auditing; competitive analysis; and general regulatory intelligence, knowledge, and strategy. RKS has aided in 16 investigational new drugs (INDs) and investigational devise exception (IDEs) and three abbreviated new drug applications (ANDAs); provided monitoring and auditing support for nine investigator-initiated clinical trials; and helped secure a Small Business Innovative Research (SBIR) award.

One of SC CTSI’s unique strengths is its long-standing partnership with the D.K. Kim International Center for Regulatory Science within the Department of Regulatory and Quality Science, a world-class training ground for professionals involved in the development and commercialization of regulated products. Three of the center’s faculty leaders form the SC CTSI RKS core, with the mandate to promote efficient, safe, compliant, and high-quality clinical studies. RKS collaborates with other cores to facilitate regulatory planning and clinical trial conduct by providing expert consultation, offering educational programs, and performing research to foster innovation in regulatory policies and practice. Its contributions have been recognized by its designation in 2019 as a Center of Excellence in Medical Device Priority Work Area.

Objective: Promote a culture of quality and streamline translation by leveraging unique USC strengths in regulatory and quality sciences to develop and disseminate best practices, conduct research, and provide direct service to clinical researchers.

Specific Aim 1. Service: Provide high-touch support throughout the life cycle of clinical protocols through a combination of consultation and establishment of standard best practices.

Specific Aim 2. Education: Expand expertise in regulatory and quality sciences in the clinical research workforce through on-site education and self-study online training modules.

Specific Aim 3. Innovation: Conduct research to address regulatory challenges in clinical research.

To see highlights of all Research Activities and the International Center, click here.

Click here for a listing of our current and future initiatives:

• Full-Day Regulatory Science Symposium for Clinical Research Professionals (current)
• Regulatory Science Research Project on Patient-Focused Drug Development (current)
• The Self-career Training, Education, Life-long Learning Advancement Resource Collaboration with Georgia CTSA (current)
• Site Preparedness for FDA inspections self-study module (newest of 3 module series)
• OpenRegSource - Regulatory Web Portal

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