Auditing Services:

GXP Consulting has conducted thousands of GxP audits globally for hundreds of clients. We offer expertise in almost every type of auditis which includes

✤ Audits of clinical investigators sites, Testing Laboratories, pharmacovigilance audits, 21 CFR Part 11Computer Systems Validation (CSV) audits, audits of clinical study & regulatory submission documents, including audits of Clinical Study Reports(CSRs), TMFs & Safety Reports

✤ Pre-Qualification and Routine audits of EDC providers, Clinical Research Organisations(CROs), Contract Manufacturing Organisations (CMO’s), Drug Depots, Labelling and Packaging Vendors, API vendors etc.

✤ Data integrity: We provide directed audits and analysis, subject matter training, procedure development, interviews of staff, internal investigations, and fraud evaluation. Throughout the process, we coordinate our efforts with your legal counsel.

✤ Qualified Person (QP) audits
All of our deliverables undergo a two-tier quality peer review internally prior to release to the client, which ensures that our clients receive the highest consistency