A UK Qualified Person and a highly skilled, experienced team who build licence applications, prepare companies for inspection and take medicines from concept to market — working directly with you, supported by our network of 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.
We run your development as one project: a single plan, budget and timeline, one point of contact, and every milestone, risk and decision tracked in our QMS. You always know where your product stands and what the next stage will cost before you commit to it.
How we charge: a free scoping call, then a fixed-fee costed plan. Every stage is priced before it starts and paid by milestone. Laboratory, bioequivalence and authority fees are passed through at cost. Lifecycle work runs on a capped monthly retainer, and smaller companies can choose a lower upfront fee with a milestone payment when the licence is granted.
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.
Oakdene is a UK company supplying established generic medicines. We designed, built and run its quality system — document control, GDP, pharmacovigilance, supplier qualification and regulatory — on the same eQMS we offer clients. We build every client's eQMS the same way: modelled on how your business works and how complex it is, integrated with the systems you already use, and introduced with the training and change management that make people use it.
Discuss a bespoke eQMS →
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.
A twenty-minute guided demo of our quality system, using synthetic data only — no client or company information is shown. A member of our team will arrange it and reply promptly.
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.
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 programmePatients 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 skilled and experienced team 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.
Your clients want to sell their medicines in the UK, but you are not based here. We are. We are building a network of trusted partners who pass work to each other. You bring your specialist skills, and we give your clients a UK base.
These 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.
A short summary of recent updates from the MHRA, EMA and ICH, compiled by GxP Pharma. 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 give you a guided demo of our eQMS and tell you honestly whether it fits your needs.
One form for every enquiry. We read every one and reply promptly.
