Expert solutions in quality management, compliance and regulatory excellence.
Designed to support your success in the pharmaceutical industry — delivered with the perspective of a former MHRA inspector.
Our services
Pharmaceutical quality & compliance.
Four core services covering the full licence lifecycle — from first application to ongoing inspection readiness.
New WDA applications & RP/RPi services
From first application to a named, trained Responsible Person — we take licences from gap analysis to grant.
New licence applications and variations
QMS development
Train new RP/RPi
Gap analyses for compliance with Human Medicines Regulations, GDP, and MHRA guidance
Expert RP/RPi services
Who it's for
Wholesalers and importers applying for a first WDA(H), varying an existing licence, or needing a named RP/RPi.
Outcome
An application that stands up to MHRA scrutiny — with a trained, supported Responsible Person behind it.
QMS & GDP consulting
Practical quality-system advice that strengthens compliance without slowing your operation.
Expert quality and compliance advice
SOP reviews & writing
Quality improvement & quality risk management
Deviation & CAPA management
Self-inspections
Who it's for
Licence holders building a quality system from scratch, or maturing one that has outgrown its paperwork.
Outcome
A QMS your team can operate day to day — proportionate, documented and defensible at inspection.
Audits of suppliers & third-parties
Independent evaluation, selection and audit of the contract acceptors your licence depends on.
Assessing suitability of contract acceptors
Preparation of quality technical agreements (QTAs)
Performance audits
Contract evaluations
Who it's for
Licence holders relying on third-party storage, transport or testing — and accountable for all of it.
Outcome
Documented assurance over every contract acceptor, graded the way an inspector would grade it.
MHRA inspection preparation & remedial actions
Get ready for a successful inspection — and close findings with responses the regulator will accept.
Inspection readiness, hosting and management of regulatory inspections
Support supplier audits
Risk identification and mitigation
Post-inspection support and remedial actions
Who it's for
Sites expecting an MHRA inspection, or responding to findings and deficiency letters already received.
Outcome
A prepared team on inspection day — and findings closed with CAPA that holds up to follow-up.
Trusted partner
Regulatory confidence, inspector-built.
Advice grounded in inspection experience — so your team knows what good looks like before the regulator arrives.
Why choose us