Your route into the UK medicines market.
TTS Worldwide is a UK-based partner for manufacturers and marketing authorisation applicants from outside the UK. We set up your UK company, arrange access to licensed wholesale and batch-release capability, take your dossier through the MHRA, and put your quality and pharmacovigilance systems in place, all as one programme run from the UK. Alongside this, our trading divisions supply pharmaceuticals and nutraceuticals across the UK, Europe and the Gulf.
Workstreams run as one programme, with a single UK point of contact
Typical time to plan for a UK marketing authorisation by the national route
MHRA timetable for International Recognition Procedure route A, where an eligible reference approval exists
UK-wide marketing authorisations have covered Great Britain and Northern Ireland since January 2025
Our three divisions
One UK partner, three ways to work with us.
Each division has its own team, processes and records. Client information from our services work is never used by our trading divisions.
Market entry & regulatory services
UK company set-up, licensed capability, MHRA filing, Responsible Person, quality systems and pharmacovigilance for international manufacturers.
The programme → Division 02Pharmaceutical sourcing & trade
Generic, branded and hard-to-find medicines for licensed buyers in the UK, Europe and the Gulf, supplied through licensed partners.
Pharmaceutical trade → Division 03Nutraceuticals & food supplements
Vitamins, minerals, botanicals and specialist nutrition, including private-label ranges, for the UK and European markets.
Nutraceuticals →Division 01 · The UK Market Entry Programme
Everything needed to file in the UK, under one roof.
Entering the UK means meeting the regulator, licensing, quality and safety requirements at the same time. We run all six workstreams together, so each part is ready when the next one needs it.
UK company & governance
Formation of your UK entity, registered office, bank account, legal formalities and programme management from day one.
Licensed capability
Arrangement agreements with third-party holders of a wholesale dealer's authorisation (WDA(H)) and a manufacturer's licence (MIA) for batch release.
Marketing authorisation
Dossier gap analysis, route selection, MHRA submission, and acting as your point of contact for all agency correspondence.
Responsible Person
An eligible, named Responsible Person to oversee Good Distribution Practice (GDP), with set-up and ongoing retained oversight.
Quality management
A quality management system built to UK GDP expectations, with SOPs, supplier qualification and continuing maintenance.
Pharmacovigilance
A pharmacovigilance system and master file, and a Qualified Person for Pharmacovigilance (QPPV) on retainer.
How an engagement runs
From first call to filed dossier.
A typical programme follows four phases. Set-up costs are fixed and agreed up front. Ongoing oversight is a monthly retainer, paid quarterly in advance.
Month 0–1
Establish
UK company formed, bank account opened, Responsible Person appointed, quality system started.
Months 1–6
Access & file
Licence-holder arrangements signed, dossier finalised and submitted, pharmacovigilance system live.
To grant, ~18 months
Assess
We handle MHRA questions and correspondence while RP, QA and QPPV oversight continue.
Ahead of launch
Launch readiness
Planning your own licences, warehousing and batch release for commercial supply.
UK regulatory insight
What overseas companies need to know.
We publish a plain-English briefing on the UK rules that shape every entry plan. These are three of the questions we answer most often.
National route or International Recognition?
When an approval from a reference regulator can shorten your UK timetable, and when the full national assessment is the better path.
Read the briefing → LicencesWDA(H), MIA and batch release
Which licences are needed for filing, which are needed for launch, and why a Qualified Person must certify imported batches.
Read the briefing → SafetyPharmacovigilance in the UK
QPPV location, the UK national contact person, master file access and reporting to the MHRA.
Read the briefing →Who we work with
Built for regulated businesses.
We work business to business. We do not supply medicines to the public.
Generic & branded producers
GMP-certified manufacturers in the Gulf, India and beyond who want a UK licence in their own name.
MA applicants & holders
Companies that hold a dossier or an approval elsewhere and need a UK filing strategy and local presence.
Distributors & investors
Groups setting up a UK pharmaceutical entity and needing its regulatory foundations built properly.
Licensed buyers & retailers
Wholesalers, pharmacies, hospitals, importers and supplement retailers in the UK, Europe and the Gulf.
Our group
A bridge between the Gulf and the UK.
TTS Worldwide is the UK business of our group. Our sister company in Dubai, Ceutica Lifesciences, works with manufacturers across the Gulf, Africa and Asia. Together we take products from those markets to a UK licence.
TTS Worldwide Limited
UK market entry, regulatory affairs, quality, pharmacovigilance and partner management.
Ceutica Lifesciences
Generics, healthcare procurement and regulatory services for the Gulf, Africa and Asia. ceuticalife.com
Our role, stated plainly
Clear about who holds each licence, at every step.
TTS Worldwide provides market-entry, regulatory, quality and pharmacovigilance services. During filing, licensed activities are carried out by third-party holders of the relevant MHRA licences. Your UK entity enters into agreements with them directly, and we arrange those agreements.
Commercial launch needs your own licences, including a warehouse. We help you plan for them as approval approaches. Our pharmaceutical trading also runs through licensed partners. We do not hold a wholesale dealer's or manufacturer's licence ourselves.
Read about our approachStart a conversation