Specialist UK services for international pharmaceutical companies.

Our flagship programme combines the six workstreams an overseas company needs to file a UK marketing authorisation in its own name.

• UK entity, banking and governance
• Access to third-party WDA(H) and MIA batch-release capability
• MA submission and MHRA correspondence
• Responsible Person, QMS and pharmacovigilance
• See the full programme →

We plan and manage your UK licence from strategy to grant, and keep it current afterwards.

• Regulatory strategy and choice of route: national assessment or International Recognition (route A or B)
• Dossier gap analysis against UK requirements, including the UK reference product for generics
• UK Module 1, summary of product characteristics, labelling and patient information leaflet
• Patient information leaflet user testing and UK Only pack artwork
• Submission via the MHRA portal, validation and responses to requests for information
• Post-approval variations, renewals and lifecycle management

Wholesale dealing in the UK requires a named Responsible Person and a working quality system. We provide both.

• Appointment of an eligible, named Responsible Person (RP), with retained oversight
• Quality manual, GDP standard operating procedures and training records
• Supplier and customer qualification, including licence checks on MHRA registers
• Temperature-control, recall, complaints and returns procedures
• Self-inspections and mock MHRA GDP inspections
• Continuing QMS maintenance, change control, deviations and CAPA

Every UK marketing authorisation holder must run a pharmacovigilance system from the day its licence is granted. We build yours in advance.

• Pharmacovigilance system and pharmacovigilance system master file (PSMF), accessible from the UK
• Qualified Person for Pharmacovigilance (QPPV) on retainer, and a UK national contact person where needed
• Case intake, processing and reporting of suspected adverse reactions to the MHRA
• Literature monitoring, signal management and periodic safety report planning
• Risk management plan support and PV audits

We give international groups a properly constituted UK base.

• Company formation and registered office in South Shields
• Bank account opening and payment set-up
• Statutory registers, legal formalities and governance support
• Programme management and reporting to your board

With our sister company in Dubai, we source and coordinate supply of quality medicines for licensed buyers in the UK, Europe and the Gulf.

• Generic, branded, OTC and hard-to-find medicines through licensed channels
• Supply to licensed wholesalers, pharmacies, hospitals and international importers
• EU supply through EU-established, licensed partners
• Supplier due diligence, qualification and full batch traceability
• Export coordination for the Gulf, Africa and Asia
• Pharmaceutical trading division →

We source and supply food supplements and nutraceuticals for the UK and European markets, and build private-label ranges for brand owners.

• Vitamins, minerals, botanicals, sports and specialist nutrition
• Private-label development, from formulation and artwork to first production run
• Label and claims review against UK and EU food law
• UK supply to retailers, pharmacies and online sellers
• EU supply through an EU-established food business operator
• Nutraceuticals division →

We help partners build their own brands, in medicines and in supplements.

• Own-label medicines: product selection, UK marketing authorisation and licensed manufacturing partners
• Private-label supplements: formulation, specifications and compliant packaging
• Artwork, leaflets and labelling coordinated for each market
• Supply-chain set-up with qualified manufacturers