GxP Auditing Services
GxP Auditing Services
GxP audits across pharmacovigilance, clinical, laboratory, manufacturing, and computerized system domains — delivered by experienced auditors worldwide.
Overview
GxP Audits
PVCON provides strategic, risk-based and independent GxP audits to evaluate regulatory compliance maturity across Pharma companies, CROs, CMOs, laboratories, vendors, and strategic partners.
Our auditors combine technical expertise and regulatory insight to deliver focused risk-assessments that strengthen governance, mitigate risk, and support inspection readiness across the product lifecycle.
The audits are conducted as on-site, virtual, and desktop/questionnaire methodologies, as required.
Audit Disciplines
Our GxP Auditing Capabilities
We provide the following comprehensive services.
Pharmacovigilance Audits
- Global PV System audits
- Country/ Local Affiliate audits
- Business Partner / Distributor audits
- Global / Local PV Service Provider audits
- MRP / PSP Vendor audits
- CAPA strategy and tracking
- PV System Gap Analysis
- Mock Inspections & Inspection readiness preparation
- Risk-based audit planning and strategy support
- Inspection documentation review
- Internal auditor training
GCP Audits
- Investigator site audits
- Clinical laboratory audits
- Phase I clinical study audits, including Bioequivalence/ Bioanalytical studies
- Phase II to IV clinical study audits
- Document audits: Protocols, ICF, IB, CRF, CSRs, PSURs, DSURs, ISS/ISE
- Clinical Database, Data Management & Biostatistics audits
- IVRS audits & Bioequivalence / Bioanalytical laboratories
- Vendor Qualification audits & FDA/EMA Mock Inspections
- Review of complete Trial Master Files (TMF) for regulatory submission
Other GxP Audits
- Computer Systems Validation (CSV) audits
- Good Laboratory Practice (GLP) audits
- Good Manufacturing Practice (GMP) audits
- Good Distribution Practice (GDP) audits
- Due Diligence audits
- For Cause audits
- Archive Facility audits
- Vendor & Supplier Qualification audits
- Regulatory submission readiness reviews
Why PVCON
Why Choose PVCON for GxP Audits?
Experienced Auditors
Our auditors average 15+ years of hands-on regulatory audit experience across multiple GxP disciplines and geographic regions.
Global Coverage
We conduct audits across 100+ countries, leveraging local regulatory knowledge and cultural awareness to deliver contextually relevant observations.
Actionable Outcomes
Every audit concludes with prioritized, practical recommendations and CAPA guidance — not just observations, but a clear path to compliance.
Ready to Elevate Your Audit Program?
Partner with PVCON for expert GxP audit services that strengthen compliance and prepare your organization for regulatory inspections.
Get in Touch