Build, remediate and embed a quality system that holds up
From a first MIA/WDA to post-inspection remediation — practical Pharmaceutical Quality Systems aligned to ICH Q10, built to be lived by your team, not just filed.
- ICH Q10 aligned
- Inspection remediation
- SOPs to qualification
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, inspection-ready quality system
Implemented from scratch or remediated where you already have gaps.
Pharmaceutical Quality System (ICH Q10)
Design and implement a right-sized PQS that satisfies EU GMP and ICH Q10.
SOPs, SMF, VMP & VPP
Core quality documentation — Site Master File, Validation Master Plan and procedures.
Deviation, CAPA & change control
Risk-based systems that keep issues controlled, investigated and closed.
OOS / OOT / OOC handling
Robust laboratory investigation processes aligned to regulatory expectations.
Self-inspection programme
An audit schedule and process that keeps you continuously inspection-ready.
Equipment & utility qualification
URS, DQ, IQ, OQ and PQ protocols and reports for facilities and equipment.
Quality / technical agreements (QTA)
Clear responsibility matrices with your CMOs, suppliers and partners.
Product Quality Reviews (PQR)
Annual product reviews and quality metrics that demonstrate control.
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.
Systems that survive contact with the real world
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
We are preparing for our first MHRA inspection — can you help?
Yes. We build the Pharmaceutical Quality System (PQS), run mock inspections and gap assessments, and prepare your team and documentation so you walk in inspection-ready.
Can you remediate findings from a recent inspection?
Yes — we translate inspection observations into a prioritised CAPA plan, implement the fixes and verify effectiveness so deficiencies stay closed.
Do you write SOPs, the SMF, VMP and quality agreements?
Yes. Quality-system documentation including SMF, VMP/VPP, SOPs, QTA, change control, deviation, OOS/OOT/OOC handling, CAPA and Product Quality Reviews.
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Build a quality system that lasts
Whether you're starting fresh or recovering from findings, let's map the fastest route to compliance.