GCP & GCLP Audit Preparation

Auditors appreciate that your data is traceable, your consent forms are signed, and your training is documented.

What I do:

• Gap analysis against ICH-GCP, SA GCP, and GCLP standards

• SOP review and recommendations

• Mock inspections and lab staff Q&A sessions

• CAPA support if you’ve had a recent finding

Outcome: You walk into the audit knowing what will be asked, with evidence to back it up.  

Best for: Sites 4 -12 weeks from inspection, new sites, or after a failed audit.  

Timeline: 2 - 4 weeks depending on lab size.

Book a "Lab Walkthrough Assessment" to find out how inspection ready you are.