Audits & Inspections

Audits and inspections are where a quality system is proven. We plan and conduct independent GxP audits, build audit programmes that satisfy EU, UK, and US expectations, and get teams genuinely ready for a health-authority inspection — not just paper-ready.

GMP · GCP · GDP audits · Supplier & vendor audits · Data integrity · Mock EMA / MHRA / FDA inspections · CAPA

What we do

A marketing authorisation, a manufacturing site, or a clinical programme is only as strong as the evidence that it actually does what its procedures say. Audits provide that evidence — for your own assurance, for partners and customers, and for regulators. We provide independent, proportionate audits and inspection support across the product lifecycle and across the EU, UK, and US.

Whether you need a one-off supplier audit, a standing audit programme, a data-integrity review, or intensive preparation before an EMA, MHRA, or FDA inspection, we scope the work to your risk, your stage, and your resources — and we translate findings into corrective actions that hold up.

Audit types

• GMP & GDP audits — manufacturing, packaging, distribution, and supply-chain audits against EU GMP/GDP, the UK regime, and US cGMP expectations.
• GCP audits — investigator sites, clinical databases, the trial master file, and CRO/vendor oversight across the trial lifecycle.
• Pharmacovigilance system audits — PV system, PSMF, and safety-process audits that feed your audit programme and CAPA.
• Supplier & vendor audits — qualification and ongoing oversight of CMOs, CROs, laboratories, and critical suppliers — remote or on-site.
• Internal audits & self-inspection — independent internal audit programmes and self-inspection support that satisfy regulatory expectations.
• Data-integrity audits — ALCOA+ reviews of records, systems, and computerised-system controls.
• For-cause audits — focused audits in response to a deviation, complaint, signal, or partner concern.

Inspection readiness

Inspections are scrutiny under time pressure. We get your people, documents, and systems ready so an inspection becomes a demonstration, not a defence.

• Mock inspections — realistic EMA, MHRA, and FDA-style mock inspections, including front-room/back-room logistics and document and sample-pull readiness.
• Inspector-facing preparation — subject-matter-expert training, narrative and storyboard preparation, and management of requests during the inspection.
• Findings & responses — support drafting responses (including mock Form FDA 483 responses) and corrective and preventive action plans that are credible and trackable.

How we work

Every audit is planned against the controlling requirement, sized to risk, and reported clearly — observations graded, root causes identified, and corrective actions practical and owned. We work to recognised audit standards and keep findings confidential and constructive.

Who we help

Emerging biotech preparing for a first inspection; manufacturers and sponsors running supplier and internal audit programmes; and organisations responding to a finding, a partner audit, or an imminent health-authority inspection.