Quality & compliance, end to end
Six focused services — from independent GMP/GDP audits and contract QP/RP/RPi cover to quality-system builds, site licensing and GDP distribution — delivered by one senior Qualified Person with 20+ years across regulated markets.
- Remote · on-site · hybrid
- UK · EU · US · MENA
- One senior expert
A complete quality & compliance toolkit
Engage a single service or combine several into an ongoing compliance partnership — each one scaled to your stage, market and budget.
GMP & GDP Audits
Independent GMP/GDP, supplier and for-cause audits, mock regulatory inspections and inspection-readiness reviews.
Learn moreContract QP, RP & RPi
Qualified Person batch certification plus Responsible Person (WDA) and Responsible Person for import (RPi) cover.
Learn moreQMS & PQS Implementation
Build and remediate quality systems to ICH Q10 — SOPs, CAPA, deviations, change control and self-inspection.
Learn moreSite Readiness (MIA / WDA)
Prepare sites, dossiers and teams for MIA/WDA licensing, regulatory inspection and operational go-live.
Learn moreSupplier & Vendor Management
GxP supplier qualification, technical/quality agreements (QTA) and ongoing performance oversight.
Learn moreGDP Transport & Supply Chain
Transport validation, cold-chain assurance and distribution compliance across the GDP supply chain.
Learn moreWhatever 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 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.
A senior, independent expert
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 a pharmaceutical quality & compliance consultant do?
We help pharma, biotech and CMOs meet GMP and GDP requirements — auditing sites and suppliers, acting as a contract QP/RP/RPi, building or remediating quality systems, and preparing teams for regulatory inspection.
Which markets and regulators do you cover?
Engagements span the UK (MHRA), European Union (EMA), United States (FDA) and the MENA region, drawing on 20+ years working to EU GMP/GDP standards.
Do you work with small, virtual or first-time pharma companies?
Yes. Whether you are a virtual company outsourcing to a CMO or preparing for your first MIA/WDA, engagements scale to your stage and budget.
Can you act as our contract QP, RP or RPi?
Yes — contract and interim QP (batch certification/release), RP (WDA) and RPi (import) cover is available. See the Contract QP, RP & RPi page for detail.
Ready to get inspection-ready?
Book a no-obligation discovery call to talk through your audit, QP/RP or quality-system needs.