Independent GMP & GDP audits that stand up to inspection
Supplier, internal and mock-regulatory audits delivered by an experienced GMP/GDP Lead Auditor — with clear, graded, regulation-mapped reports your team can act on immediately.
- Supplier & for-cause audits
- Remote, on-site or hybrid
- Graded, actionable reports
Whatever stage of compliance you're at
Stay ahead of inspections, keep routine compliance on track, or recover quickly when something goes wrong.
Inspection Readiness
- Mock regulatory inspections
- GMP/GDP gap assessments
- Pre-approval inspection prep
- Self-inspection programmes
Routine Compliance
- Scheduled supplier audits
- Periodic self-inspections
- QMS / PQS health checks
- QP / RP oversight
Remediation & CAPA
- For-cause & triggered audits
- Post-inspection remediation
- CAPA design & effectiveness
- Data-integrity reviews
Every audit you're likely to need
Across GMP and GDP, planned or triggered — scoped to your product, site and regulatory context.
Supplier & third-party audits
Qualify and monitor CMOs, API and material suppliers and service providers against your quality agreements.
Internal & self-inspection
Independent self-inspections that satisfy EU GMP Chapter 9 and GDP self-inspection expectations.
Mock regulatory inspections
Realistic MHRA/FDA-style dry runs that test readiness and rehearse your team before the real inspection.
Pre-approval & for-cause audits
Targeted assessments ahead of approval, or in response to a specific trigger, complaint or quality signal.
GMP / GDP gap assessments
Benchmark a site, supplier or system against the applicable GxP requirements and prioritise the gaps.
Data-integrity reviews
ALCOA+, EU Annex 11 and 21 CFR Part 11 assessment of records and computerised systems.
Standards we audit & build against
Across product types and the regulatory frameworks that govern them — UK, EU and US.
- Sterile & non-sterile medicinesEU GMP — EudraLex Vol. 421 CFR 210/211ICH Q7–Q10
- Biologics & biosimilarsEU GMP Annex 1/2ICH Q5/Q621 CFR 600s
- APIs, raw materials & excipientsICH Q7EXCiPACTEudraLex Vol. 4 Part II
- Distribution & importationEU GDP 2013/C 343/01MHRA WDA(H)GDP RPi
- Computerised systems & dataGAMP 521 CFR Part 11Annex 11 / ALCOA+
- Medical devices & combinationISO 13485ISO 9001ISO 14971
A clear, inspection-grade method
Every engagement follows the same disciplined path — so you always know what happens next.
- 01
Scope & risk assessment
We agree objectives, the regulatory basis and risk priorities so effort lands where it matters most.
- 02
Plan & prepare
A clear agenda, document requests and logistics — delivered on-site, remote or hybrid to suit your site.
- 03
Execute
Rigorous, experienced assessment against the applicable GxP requirements — or hands-on implementation work.
- 04
Report
Clear, graded findings mapped to regulations and ranked by risk, so your team knows exactly what to fix first.
- 05
CAPA & follow-up
A practical corrective-action plan, effectiveness checks and re-assessment to close the loop and stay inspection-ready.
An inspector's eye, an operator's pragmatism
No layers, no juniors learning on your time — direct access to a Qualified Person who has sat on both sides of the inspection table.
An ex-industry QP perspective
Audits and advice from someone who has held QP, RP and RPi roles and hosted regulatory inspections — not theory.
UK, EU, US & MENA experience
20+ years harmonising quality systems and supporting batch release across highly regulated global markets.
Sterile to solid oral dose
Deep experience across sterile injectables, oncology, biosimilars, solid oral dose, APIs and excipients.
Reports you can act on
Findings graded by risk and mapped to the regulation — clear enough to take straight into CAPA.
Flexible delivery
On-site, remote or hybrid engagements scaled to a single audit or an ongoing compliance partnership.
One senior point of contact
You work directly with a senior expert from first call to final sign-off — no hand-offs, no juniors.
Frequently asked questions
What types of GMP audit do you carry out?
Supplier and third-party audits, internal/self-inspections, mock regulatory inspections, pre-approval inspection preparation and for-cause (triggered) audits across GMP and GDP.
Do you offer remote, on-site or hybrid audits?
All three. Many supplier and documentation audits run effectively remotely; sterile and complex sites usually benefit from on-site or hybrid assessment.
What will the audit report look like?
A clear report with findings graded by risk and mapped to the relevant regulation (e.g. EudraLex Vol. 4, 21 CFR 210/211), plus practical recommendations ready to feed into CAPA.
Which standards and product types can you audit against?
EU GMP, FDA 21 CFR 210/211, ICH Q-series, EU/MHRA GDP, ISO 13485/9001 and GAMP 5 — across sterile and non-sterile medicines, biologics, APIs, excipients and distribution.
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Book your GMP/GDP audit
Tell us about your site, supplier or upcoming inspection and we'll propose a scope and timeline.