Overview — Regulatory OperationsInstitutional Office of Regulated Nonclinical Studies (ORNcS)


The Institutional Office of Regulated Nonclinical Studies (ORNcS) provides the infrastructure to support regulated studies performed under Quality Management Systems (QMS) utilizing the FDA Good Laboratory Practice (GLP) regulations (21 CFR Part 58) as a reference standard. These studies are planned, performed, monitored, documented, reported, and archived.

The ORNcS contains a Regulatory Science and a Regulatory Operations branch that operate in parallel to lead the conduct and oversight of regulated studies. The Regulatory Science branch directs the planning and conduct of regulated studies under the direction of a Study Director, whereas the Regulatory Operations branch provides regulatory oversight via independent Quality Assurance Unit (QAU) inspections along with quality control (QC) review to assure the accuracy and completeness of records prior to QAU inspection. The regulation operations branch also provides document control and archival of regulated study records. Click below to discover more information on the ORNcS, specifically how the Regulatory Operations branch supports and provides oversight of regulated studies at UTMB.


Contact Us

Institutional Office of Regulated Nonclinical Studies
University of Texas Medical Branch at Galveston
2.810 Rebecca Sealy, Route 0184
301 University Blvd.
Galveston, TX 77555
Phone: (409) 747.8138
Email: ORNcS@utmb.edu