AuraGxP Audit Services

Strengthen compliance and pass inspections with risk-based GxP audits.
Tailored audit services across the life sciences value chain — from clinical trials and manufacturing to IT systems.

Audit expertise tailored to your stage and maturity. Whether you're launching your first product, scaling manufacturing, or managing a post-marketing portfolio, our audits deliver practical findings and actionable recommendations aligned to your regulatory environment and business model.

OUR CAPABILITIES

Five pillars of GxP audit expertise

1. Good Clinical Practice (GCP)

We help sponsors, CROs, and investigator sites assess compliance across planning, conduct, documentation, and reporting — supporting routine, targeted, and for-cause audits, GxP, CRO, TMF reviews, data management audits, mock inspections, and vendor oversight assessments aligned to ICH E6(R3).

Investigator site: conduct audits and essential document reviews
Sponsor and CRO systems: oversight processes and audit trails
Trial Master File: completeness and quality
Protocol, informed consent, and clinical report documentation
Clinical vendors — data management, biostatistics, translation, central imaging/ECG

2. Good Manufacturing Practice (GMP)

Our GMP audits support drug product, drug substance, and supply chain operations across sterile and non-sterile manufacturing environments — assessing quality systems, batch controls, facilities, utilities, laboratory operations, and supplier oversight.

Manufacturing operations for sterile and non-sterile dosage forms
APIs, excipients, packaging, labelling, warehouse, and distribution
Laboratory, calibration, maintenance, and environmental controls
Batch disposition and quality oversight processes
Facility assessments to identify gaps in execution and documentation

3. Computer Systems Compliance (CSC)

In regulated environments, computerised systems must maintain validated state and data integrity. We audit:

Vendor assessments: software and technology provider audits for security, validation, and compliance
System validation: initial qualification and periodic revalidation of computerised systems
Lifecycle management: system development, deployment, change control, and decommissioning practices
Data integrity & access controls: audit trails, user access, traceability, and compliance controls

WHY AURAGXP

The standard your compliance programme deserves

Independent Assurance

A third-party perspective free from internal bias. When your leadership and regulators see an AuraGxP report, they know the findings are credible; backed by auditors with no incentive to downplay risks.

Risk-Based Approach

Audit scope and depth calibrated to your organisation's maturity, regulatory exposure, and business model.

Deep Regulatory Knowledge

Auditors with hands-on experience of FDA, EMA, MHRA, and PMDA expectations across multiple GxP disciplines.

Actionable Reporting

Clear, concise audit reports with risk-rated observations and practical remediation guidance — not just a list of findings.

Collaborative Partnerships

We work alongside your teams with a constructive mindset, building internal capability alongside delivering audit outcomes.

Global Reach

Audit programmes delivered across Europe, North America, and Asia-Pacific — with multilingual support where required.

Ready to strengthen your compliance? Contact us for an audit assessment. We'll identify gaps, prioritize remediation, and outline a path to inspection readiness.

FAQ