The mission for the Institutional Office of Regulated Nonclinical Studies (ORNcS) is to provide scientific support and regulatory oversight during the planning and conduct of in vitro and in vivo nonclinical studies where derived data are intended to
support applications for research or marketing permits for products regulated by the Food and Drug Administration, including products submitted via the Animal Rule pathway.
The Institutional Office of Regulated Nonclinical Studies (ORNcS), established under the direction of the Executive Vice President and Provost/Dean of the School of Medicine, provides the infrastructure to support regulated studies performed under Quality
Management Systems (QMS) utilizing the GLP regulations as a reference standard. An Institutional Policy (IHOP) describes the requirements for involvement of the ORNcS. These studies are prospectively planned, performed, monitored, documented, reported,
ORNcS partners with scientific teams to provide regulatory strategy to facilitate licensure and documentation for development of new drugs and biologics. Project milestones and contract deliverables are negotiated through the ORNcS in coordination with
appropriate scientific subject matter experts. Execution of the study is performed under the direction of an ORNcS Study Director and in compliance with the study protocol and standardized laboratory procedures. Compliance monitoring is conducted
by an independent Quality Assurance Unit (QAU).
To separate study conduct from regulatory oversight, the ORNcS consists of a Scientific branch and a Regulatory Operations branch that operate in parallel to support regulated studies. The Scientific branch provides oversight for the planning and conduct
of regulated studies under the direction of a Study Director. The Regulatory Operations branch provides regulatory oversight via independent Quality Assurance Unit (QAU) inspections along with document control, quality control, and retention capabilities.
For more specific information, visit the sites below:
For more information on the UTMB’s IHOP, the FDA Animal Rule, the Collaborative Educational Program with the FDA Office of Counterterrorism and Emerging Threats, ORNcS involvement during funding submissions, and regulatory requirements, click on the links below:
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