Regulatory Operation Services

The Regulatory Operations Team is independent from study conduct and provides support and oversight of nonclinical regulated studies. Services are integrated into the planning and conduct of regulated studies and require pre-submission discussion for incorporation. Below is a general list of responsibilities:

QAU critical phase inspections
QAU facility audits
QAU data verification reviews
Host of Agency and Sponsor audits
Host of Sponsor qualification audits
QC of data and collection forms for GDP prior to QA review

Secure SOP management and distribution via Electronic Document Management System (EDMS)
Document retention and archival of regulated studies
Development and negotiation of Quality Agreements
Regulatory consulting
Submission Proposal review (collectively with ORNcS Regulatory Science Branch)
Education (please see Education and Resources Section)