Quality Assurance

Neozene provides high-level clinical quality assurance and auditing services to prepare personnel and clinical research data for interaction with and review by the FDA, thereby reducing costs and drug development time.

Through early identification and effective resolution of potential issues before an FDA audit, you can be sure that those managing your considerable investment in clinical research are in compliance with drug development regulations.

Neozene Quality Assurance Services include:

• Investigator / Study Site Audit
• Sponsor / Contract Research Organization Audits
• Institutional Review Board Audits
• Data and Report Audits
• Regulatory Submissions