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.