Capabilities & Skills

Assessments of Post-Marketing Patient Support Programs

Corporate Audits

Due Diligence

Inspection Readiness Support

Investigator Site Audits

Mock Regulatory Inspections

Process Audits

 

Quality SOP Preparation

Quality System Assessments and Remediation

Regulatory Document Audits

Regulatory Inspection

Third Party Organization Audits and Remediation

Trial Master File Assessments