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)