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.
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.
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