Fee for Service / OCR Regulatory

OCR Regulatory provides regulatory expertise to faculty conducting (i) investigator initiated clinical trials, (ii) non-clinical IND enabling studies, and (iii) manufacturing for use in clinical trials. In addition, the team manages Penn held INDs and IDEs, supports high-risk first-in-human trials sponsored by Penn faculty, trains and qualifies faculty sponsors, reviews IND and IDE exemption requests, and provides intensive support to faculty translating research from Penn labs into clinical development. 

OCR Regulatory provides both free and fee-for-service support.

For an overall description of services offered by OCR Regulatory, please visit this page.

For more information on fee-for-service support offered, visit the OCR Regulatory fee-for-service page or contact us via psom-ind-ide@pobox.upenn.edu or 215-662-4484.