Our Integrated Approach

As sponsors, sites and FDA resume normal operations post-pandemic, the MCRA CQA team is ready to provide guidance and support to sponsors and sites to confirm they are prepared for the increase in on-site regulatory inspections.

MCRA’s CQA expertise includes, but is not limited to, FDA inspectional processes, GCP compliance and training, support with Clinical CAPAs, site audits, vendor/supplier qualification, and computer systems validation.

CQA Service Offerings:

  • Quality Management System Gap Assessments for ICH GCP & ISO 14155
  • SOP Development Support
  • Risk Assessment & Management
  • FDA Inspection Readiness Evaluation & Training
  • Clinical Investigator Site SOP Development
  • Routine & For Cause Site Audits


Contact a Clinical quality Expert