Our services range from performing a “diagnostic” review of a PV system or Clinical Research program to providing input on development and resolution of corrective and preventive action plans to full auditing.

Includes

• Designing a risk-based and robust audit program
• Global health authorities (including European GVP Modules I and IV)
• Performing audits of PV systems or Clinical Research programs
• Good Pharmacovigilance Practices (GVP) or Good Clinical Practices (GCP)
• Perform a PV system or Clinical Program “diagnostic” review
• Development and execution of robust action plans to close gaps, including documentation