Frequently asked questions

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.

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.

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.

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.

Supplier and third-party audits, internal/self-inspections, mock regulatory inspections, pre-approval inspection preparation and for-cause (triggered) audits across GMP and GDP.

All three. Many supplier and documentation audits run effectively remotely; sterile and complex sites usually benefit from on-site or hybrid assessment.

A clear report with findings graded by risk and mapped to the relevant regulation (e.g. EudraLex Vol. 4, 21 CFR 210/211), plus practical recommendations ready to feed into CAPA.

EU GMP, FDA 21 CFR 210/211, ICH Q-series, EU/MHRA GDP, ISO 13485/9001 and GAMP 5 — across sterile and non-sterile medicines, biologics, APIs, excipients and distribution.

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.

Yes — from short-term interim cover during recruitment or absence, through to an ongoing named-person arrangement, subject to scope and eligibility checks.

Sterile injectables (liquid and freeze-dried), oncology injectables, biosimilars and solid oral dose, alongside APIs and raw materials oversight.

Yes. CMO oversight, technical/quality agreements (QTA) and supplier qualification can be combined with QP/RP duties for end-to-end assurance.

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.

Yes — we translate inspection observations into a prioritised CAPA plan, implement the fixes and verify effectiveness so deficiencies stay closed.

Yes. Quality-system documentation including SMF, VMP/VPP, SOPs, QTA, change control, deviation, OOS/OOT/OOC handling, CAPA and Product Quality Reviews.

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.

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.

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.

Yes. Manufacturing/Import Authorisation (MIA / MIA(IMP)) and Wholesale Dealer’s Authorisation (WDA(H)), including the importation (RPi) route.

A risk-based programme: criticality assessment, questionnaires, document review and on-site or remote audits where warranted, with a defined re-qualification cycle proportionate to risk.

Yes — clear QTAs that define quality responsibilities between you and your CMOs, suppliers and service providers, aligned to EU GMP Chapter 7.

Yes. Scheduled and for-cause supplier/third-party audits, performance monitoring (KPIs, complaints, deviations) and escalation when a supplier drifts out of specification.

API and excipient manufacturers, CMOs, packaging, laboratories, calibration, logistics and other GxP service providers across your supply chain.

Demonstrating that your distribution routes, packaging and processes keep products within their required conditions — temperature mapping and qualification of lanes, packaging and vehicles, plus a control strategy for excursions.

Yes — cold-chain qualification, temperature mapping of stores and shipping, monitoring strategy and excursion management for refrigerated and frozen products.

Yes. GDP gap assessments against EU GDP (2013/C 343/01) and MHRA expectations, plus Responsible Person (RP) and RPi support under your WDA.

Yes — root-cause investigation, risk assessment of product impact, and CAPA to prevent recurrence across the supply chain.