Contract Qualified Person & Responsible Person cover
Named QP, RP and RPi support for UK and EU operations — from interim cover to an ongoing arrangement, backed by 20+ years of batch release and inspection experience.
- Batch certification & release
- WDA & import (RPi)
- Interim or ongoing
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
QP, RP and RPi — what's the difference?
Three distinct regulatory roles. We can provide cover for each, individually or combined.
Qualified Person (QP)
Certification and release of medicinal product batches under your Manufacturing/Import Authorisation (MIA / MIA(IMP)).
Responsible Person (RP)
Oversight of GDP compliance for wholesale distribution under a Wholesale Dealer's Authorisation (WDA(H)).
RP for import (RPi)
The named role overseeing importation of medicines into Great Britain from approved countries.
End-to-end release and distribution assurance
Batch certification & release
Disposition decisions for sterile, oncology, biosimilar and solid-oral-dose products.
Interim & ongoing cover
Short-term cover during recruitment or absence, or a standing named-person arrangement.
CMO & supplier oversight
Technical/quality agreements (QTA), supplier qualification and ongoing performance review.
Importation oversight
RPi duties, confirmation of QP certification and import documentation review.
Deviation & release support
Risk-based handling of deviations, OOS/OOT and complaints affecting release.
Eligibility & gap checks
An honest assessment of scope, eligibility and what's needed before we start.
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.
Senior cover you can rely on
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 is the difference between a QP, an RP and an RPi?
A Qualified Person (QP) certifies and releases medicinal product batches under an MIA. A Responsible Person (RP) oversees GDP compliance under a WDA. An RPi (RP for import) covers importation of medicines from outside the UK/EEA.
Can you provide interim or ongoing QP/RP cover?
Yes — from short-term interim cover during recruitment or absence, through to an ongoing named-person arrangement, subject to scope and eligibility checks.
Which product types can you support for batch release?
Sterile injectables (liquid and freeze-dried), oncology injectables, biosimilars and solid oral dose, alongside APIs and raw materials oversight.
Do you also manage our CMOs and suppliers?
Yes. CMO oversight, technical/quality agreements (QTA) and supplier qualification can be combined with QP/RP duties for end-to-end assurance.
Related services
Need QP, RP or RPi cover?
Tell us about your authorisation, products and timelines and we'll confirm scope and eligibility.