A UK Qualified Person who builds licence applications, prepares companies for inspection and takes medicines from concept to market — working directly with you, alongside a small team in India and international associates.
End-to-end support from specialists who have built UK licence applications and quality systems from the ground up.
Most overseas manufacturers juggle a regulatory consultant, a pharmacovigilance provider, a laboratory, an auditor and a distributor. We bring them together behind one contract and one quality system.
Patients depend on medicines that are safe, effective and always available. Everything we do starts there. We help pharmaceutical companies and the people in them build quality in from the first idea to commercial supply, so products reach patients safely and without avoidable delay.
Led personally by Tushar Patel from Cambridge, UK, with a small dedicated team in India and a growing network of trusted associates internationally — so you get senior UK judgement on every piece of work, and the capacity to deliver it.
Consultancy, training and a digital QMS, across all GxP disciplines, on one platform.
Four things an MHRA inspector looks for — shown in our guided demo before you sign anything. It runs on synthetic data, so nothing confidential is ever on screen.
Every controlled document has one register entry: version, scope, owner, review date. Nothing lives in a shared drive.
Scan one to confirm you have read this version. Scan the other to report a problem with it, even without a login.
Training is assigned by role and tracked by document version, so a gap shows before the task is done.
Deviations, CAPA and audit findings sit on one readiness view. Finding and fixing your own problems is the point.
Twenty minutes through our own quality system, running on the demo environment with synthetic data — no client or company information is shown. A person sets it up and replies within one working day.
We run the whole programme: one plan, one timeline and one point of contact, with every milestone tracked in our QMS so you always know where your product stands.
GxP Pharma manages your testing and development programme end to end. The laboratory work is carried out at an MHRA-approved partner laboratory, under a quality agreement we hold and oversee — so you deal with one team, one quality system and one set of reports.
Most UK and EU products depend on API and finished-product sites overseas. GxP Pharma manages audits, engineering and technical work at those sites through an international partner network, reviewed against UK and EU expectations by our own team before anything reaches you.
GxP Pharma and our sister company Oakdene Pharmaceuticals are completing MHRA licensing, so the whole route — from import and QP certification to UK wholesale supply — sits with one group.
We are inviting a small number of manufacturers to be the first products through it. Talk to us now and your products can be ready when the licences are.
Join the early access programmeThese services are in development and not yet available. Tell us if you want them and we will come back to you when they open.
Bringing medicines that already hold a marketing authorisation into the UK from other markets and repackaging them to UK requirements. This depends on Oakdene Pharmaceuticals’ WDA(H) being granted and on a separate parallel import licence (PLPI) for each product.
Regulatory and quality support for veterinary products. Veterinary medicines in the UK are regulated by the Veterinary Medicines Directorate, not the MHRA, and need their own authorisations and their own quality system scope.
Acting as UK Responsible Person (UKRP) for overseas device manufacturers, with UKCA conformity support and post-market surveillance. The UKRP is the device role under the UK MDR and is not the same as a GDP Responsible Person.
Your clients want the UK and you can't serve them from where you are. We can. We're building a network of associates who send each other work — you bring the capability, we bring the UK front door.
Oakdene is a UK company supplying established generic medicines. GxP Pharma built and runs its quality system — document control, GDP, pharmacovigilance, supplier qualification and regulatory — on the same eQMS we offer clients.
Ask about the case study →
Three decades of experience, shared freely. Level 1 of our four-level pathway: a plain-English, two-page guide for each discipline — the essentials, key terms, UK and EU references, and what inspectors find most often. Free to download.
Compiled by GxP Pharma from MHRA, EMA and ICH sources, and checked by Tushar Patel before publishing. Week of 21 September 2026.
Summaries are general information, not advice. Always read the original source.
No one is an expert in everything, so we bring in the best specialist for each GxP discipline. If you are one of them, we would like to hear from you — and we make it worth your while.
We walk you through our eQMS live and tell you honestly whether it fits your needs.
One form for every enquiry. We read them all and reply within one working day.
