Keep every shipment compliant & in-spec
Transport validation, cold-chain assurance and distribution compliance to EU GDP — so your products reach patients within specification, every time.
- Transport validation
- Cold-chain mapping
- EU GDP 2013/C 343/01
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
End-to-end distribution compliance
From the loading bay to the patient — validated and controlled.
Transport validation
Qualify routes, lanes, packaging and vehicles so products stay within their required conditions.
Cold-chain & temperature mapping
Mapping and qualification of stores and shipping for refrigerated and frozen products.
GDP gap assessments
Benchmark distribution against EU GDP (2013/C 343/01) and MHRA expectations.
WDA & RP / RPi support
Responsible Person duties and wholesale-dealer compliance under your WDA(H).
Excursion & deviation management
Root-cause investigation and product-impact assessment for temperature excursions.
Supply-chain risk
Identify and mitigate distribution risks across the end-to-end chain.
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.
Distribution you can defend in an inspection
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 does transport validation involve?
Demonstrating that your distribution routes, packaging and processes keep products within their required conditions — temperature mapping and qualification of lanes, packaging and vehicles, plus a control strategy for excursions.
Can you help with cold-chain and temperature-sensitive products?
Yes — cold-chain qualification, temperature mapping of stores and shipping, monitoring strategy and excursion management for refrigerated and frozen products.
Do you provide GDP gap assessments and RP support?
Yes. GDP gap assessments against EU GDP (2013/C 343/01) and MHRA expectations, plus Responsible Person (RP) and RPi support under your WDA.
Can you investigate a temperature excursion or distribution deviation?
Yes — root-cause investigation, risk assessment of product impact, and CAPA to prevent recurrence across the supply chain.
Related services
Need GDP or cold-chain support?
Tell us about your routes, products and temperature requirements and we'll propose a validation and compliance plan.