Quality & Compliance · Auditing
Find It Before
The Inspector Does.
Independent GCP, GMP, and GVP audits that surface what regulators would find — before they find it.
GCP·GMPGLP · GVP
Overview
Audits Structured Like a Real Inspection
GxP auditing services exist for one reason: to find compliance gaps before a regulatory inspector does. Pharma audit services that produce clean reports when the underlying quality systems are not clean are worse than no audit at all — they create false confidence that accelerates inspection failure. Our auditors are experienced in how FDA, EMA, and MHRA actually conduct inspections, and they look for the same things inspectors look for, in the same order, with the same level of forensic documentation review. The gap between what a quality system says it does and what it actually does is where most inspection findings originate — and it is exactly what we are trained to find.
- Independent GCP, GMP, GLP and GVP audits
- Vendor qualification and internal audits
- Findings written to inspection standard
- CAPA tracked to verified closure
What We Deliver
Capabilities Across Every Stage
Three integrated disciplines, delivered by senior specialists as one accountable programme.
GMP, GCP, GLP Audits
GMP GCP GLP audits across all three Good Practice domains require different methodological approaches. GMP audits examine manufacturing processes, batch record review, change control systems, and environmental monitoring. GCP audits focus on trial conduct, informed consent, source data integrity, monitoring oversight, and Trial Master File completeness. GLP audits assess laboratory study conduct, equipment calibration, and data integrity controls. Quality audit pharma work is conducted by auditors with domain-specific experience. Regulatory compliance audits are structured against current inspection expectations — because what agencies cite in findings sometimes leads the published guidance. CRO audit services cover the assessment of CRO quality systems, SOPs, staff qualifications, and performance track record.
Vendor Qualification & Internal Audits
Vendor qualification audits establish that prospective CROs, CMOs, and laboratories have the quality infrastructure to perform the contracted work. Our qualification audits are scoped to the specific risk profile of the vendor relationship — a central laboratory for a pivotal study is audited with more intensity than a low-risk supplier. Internal audit pharma programmes are most valuable when genuinely independent — conducted by auditors who will document findings accurately regardless of the seniority of the people responsible. Audit consulting pharma engagements support organisations in designing internal audit programmes, training internal auditors, and building the audit governance frameworks that regulators expect to see at inspection.
CAPA & Compliance
CAPA management services are where audit value is realised or lost. A finding without a root cause analysis and a corrective action addressing that root cause is a finding that will recur — and regulators know this. Inspection readiness audits are conducted before an anticipated regulatory inspection to identify and remediate significant compliance gaps while there is still time. Global GxP compliance programmes for multi-site organisations require a consistent audit standard applied locally. For sponsors requiring global GxP audit services USA EU UK under a single quality assurance framework — pharma audit consulting worldwide.
GxPAll Domains
4Global Regions
CAPATo Verified Closure
ISO 90012015 Quality System
Key Deliverables
What You Receive
Tangible, submission-ready outputs — not status updates.
Audit Plan
Risk-based plan covering scope, schedule, regulatory standards, and audit team composition.
Audit Report
Structured findings report with risk classifications, observations, and corrective action recommendations.
CAPA Tracker
Live tracking document managing corrective and preventive actions through to verified closure.
Vendor Qualification Certificate
Formal qualification record confirming vendor suitability and the basis for the qualification decision.
Why Vigilare
Why Sponsors Choose Vigilare
What sets this engagement apart from a generic vendor.
Ex-Inspector Auditors
Auditors with direct regulatory inspection experience — including former FDA, EMA, and MHRA inspectors and advisors — who know what inspectors look for because they have conducted inspections themselves.
Inspection-Grade Findings
Audit findings written to the standard of a regulatory inspection observation — specific, evidence-based, risk-rated, and actionable — not broad commentary that cannot be translated into CAPA.
Current Focus Intelligence
Current inspection focus area intelligence applied to every audit — covering FDA and EMA inspection trends that may not yet be reflected in published guidance but are actively cited in recent inspection reports.
CAPA to Closure
CAPA support through to verified closure — not limited to finding identification, but tracked through root cause analysis, corrective action implementation, and effectiveness verification.
Who We Work With
Configured to Your Model
We engage differently depending on the function you already have in place.
Sponsors Preparing for Inspection
Challenge
Facing imminent FDA, EMA, or MHRA inspection needing independent assessment of readiness
How We Help
Pre-inspection audit surfacing findings a regulator would raise, with prioritised remediation support.
CROs Seeking Qualification
Challenge
Need to demonstrate quality system capability to sponsor clients through independent audit
How We Help
Qualification audits and certificates satisfying sponsor quality requirements.
CMOs & Manufacturers
Challenge
Require ongoing GMP system auditing to maintain compliance across manufacturing sites
How We Help
Scheduled internal auditing programmes with consistent reporting and integrated CAPA tracking.
FAQs
GxP Auditing, Answered.
01
What is GxP auditing?
GxP auditing refers to systematic, independent assessments of quality systems and processes against the Good Practice regulatory standards that apply to pharmaceutical development and manufacturing — GCP for clinical trials, GMP for manufacturing, GLP for non-clinical research, and GVP for pharmacovigilance. GxP audits identify gaps between current practice and regulatory requirements before those gaps are discovered during a regulatory inspection.
02
How to perform pharma audits?
A pharmaceutical audit is conducted by developing a risk-based audit plan that defines scope, applicable regulatory standards, and audit team composition; conducting document review, staff interviews, and process observation; identifying findings and their root causes; producing a structured report with risk ratings; and tracking corrective and preventive actions through to verified closure. Effective pharma audits require auditors with domain-specific knowledge of the GxP standards being assessed and current awareness of regulatory inspection focus areas.
Related Services
Complete the Quality System
Combine this with the wider quality and compliance programme under one framework.
Ready to schedule an audit?
Speak to our team about your programme requirements. We respond within one business day.