Supplier quality you can actually rely on
Risk-based GxP supplier qualification, technical/quality agreements and ongoing oversight — so every link in your supply chain stays compliant and audit-ready.
- Risk-based qualification
- QTAs (GMP Ch. 7)
- Audit programmes
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
A complete supplier-management programme
Qualify, agree, audit and monitor — proportionate to risk.
Risk-based qualification
Criticality assessment, questionnaires and document review to qualify new suppliers proportionately to risk.
Supplier & third-party audits
On-site or remote audits of API and excipient makers, CMOs, packaging, labs and logistics providers.
Technical / quality agreements
Clear QTAs that define quality responsibilities, aligned to EU GMP Chapter 7.
Ongoing performance oversight
KPIs, complaint and deviation trending, with escalation when a supplier drifts out of spec.
Re-qualification cycle
A defined, risk-based schedule that keeps your supplier approvals current.
Supply-chain mapping
Document the full chain so risks, single points of failure and dependencies are visible.
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.
Supply-chain assurance, end to end
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
How do you qualify and risk-rate suppliers?
A risk-based programme: criticality assessment, questionnaires, document review and on-site or remote audits where warranted, with a defined re-qualification cycle proportionate to risk.
Can you write our technical/quality agreements (QTAs)?
Yes — clear QTAs that define quality responsibilities between you and your CMOs, suppliers and service providers, aligned to EU GMP Chapter 7.
Do you run ongoing supplier audits?
Yes. Scheduled and for-cause supplier/third-party audits, performance monitoring (KPIs, complaints, deviations) and escalation when a supplier drifts out of specification.
Which suppliers does this cover?
API and excipient manufacturers, CMOs, packaging, laboratories, calibration, logistics and other GxP service providers across your supply chain.
Related services
Need stronger supplier oversight?
Tell us about your suppliers and CMOs and we'll propose a risk-based qualification and audit programme.