cGMP and GCP Audits

cGMP Internal Audits

Mock Pre-Approval Inspections (PAI’s)

License application/Submissions versus actual practice

Validation Programs and Protocols

Training Programs

Product Complaint/Adverse Event Reporting Programs

Change Control Programs

Laboratory and OOS Investigations

Stability Programs

Process Deviations and Non-conforming Materials

Clinical Supply Manufacturing and Controls

Supplier Quality Programs

21CFR Part 11 Compliance

Mock Recalls

Other QA/QC/Regulatory Programs and Systems

GCP Audits

Clinical Site Selection

Clinical Site Follow-up

Analytical Laboratories

Contract Research Organizations 

cGMP External Audits

Vendor Audits

Contract Manufacturers and Packagers

Active Ingredient/Raw Material Suppliers

     Label/Package Component Suppliers

Contract Laboratories

Service Providers