Get your site licence & inspection ready
From a first MIA/WDA application to operational go-live — gap assessment, remediation, mock inspection and team preparation so you pass and start licensed operations on time.
- MIA · MIA(IMP) · WDA(H)
- Mock pre-licensing inspection
- QP / RP / RPi support
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
Everything between application and go-live
A clear path to a licensed, inspection-ready site.
Licence application support
MIA / MIA(IMP) / WDA(H) applications and the supporting documentation, including the Site Master File (SMF).
QMS & facility gap assessment
Benchmark your quality system, facility and processes against the licence requirements and prioritise the gaps.
QP / RP / RPi nomination
Help identify and prepare the named person(s) the licence requires, with interim cover where needed.
Mock pre-licensing inspection
A realistic MHRA-style inspection to test readiness and rehearse your team before the real one.
Remediation & CAPA
Close the gaps with a practical, prioritised action plan and verify effectiveness.
Operational go-live
Final readiness checks so you can begin licensed operations with confidence.
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.
An inspector's eye on your readiness
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 ‘site readiness’ actually involve?
Getting a site, its quality system, documentation and team to the point where they can pass a regulatory pre-licensing inspection and begin licensed operations — covering gap assessment, remediation, mock inspection and go-live support.
Can you help with the MIA or WDA application itself?
Yes — we support the licence application and supporting documentation (e.g. the Site Master File), help nominate the QP/RP/RPi, and prepare you for the MHRA inspection that precedes the licence.
How early should we engage you?
As early as possible — ideally before the application — so gaps are found and fixed on your timeline rather than during an inspection. We can also help recover a stalled application.
Do you cover both manufacturing and wholesale dealer sites?
Yes. Manufacturing/Import Authorisation (MIA / MIA(IMP)) and Wholesale Dealer’s Authorisation (WDA(H)), including the importation (RPi) route.
Related services
Preparing for an MIA or WDA?
Tell us your target licence, site and timeline and we'll map the fastest route to inspection-ready.