Two weeks after you send us the product — a device or a medicine — you get a document that tells you what each market actually requires, what the whole thing costs including official fees, what is missing from your file — and whether it is worth doing at all this year.
Everyone in this market offers a free consultation. What you get is forty minutes of generalities and a proposal. The reason is simple: nobody can afford to do real work for free, so the free version contains no real work.
The assessment is real work. Someone reads your technical file or your dossier, checks the current requirements against the regulator's own publications, prices the route line by line and talks to representatives in the market. That takes days, and it produces something you can use even if you never hire us again — including, quite often, the conclusion that a different market should come first.
It is also how we qualify you, honestly. A company that will not spend £1,450 to find out what a £20,000 project involves is not going to enjoy the project. Both sides find that out cheaply, in two weeks, instead of expensively, in six months.
These are not abstractions. Each one is a specific, published consequence of getting the first fortnight wrong.
Nigeria publishes 36 actives that may be registered only as locally manufactured, and 29 more under a migration policy. NAFDAC states it will not entertain a new application — or a renewal — for an imported product on either.
A South African single exit price is unregulated when you declare it and fixed forever after. The only lawful increase is the Minister's annual percentage, 1.47% for 2026, on a method the Department declines to publish.
Article 6(1) of the Turkish licensing regulation admits only applicants established in Türkiye. There is no non-resident holder and no agent-on-the-file arrangement. That decision precedes the choice of partner.
SFDA fees are paid at submission and are not returned when a file is incomplete. Argue the class wrong and a Class B resubmission costs SAR 19,000 twice, not once.
Saudi Arabia wants one representative with exclusivity confirmed to the regulator. The UAE requires at least two importers by statute. One distributor agreement cannot satisfy both.
Where an authorisation cannot be moved, finding it in your distributor's name is not a paperwork problem. It is the price of the whole registration again, from a weaker position.
Each of these is traced on the market page it comes from — Saudi Arabia and United Arab Emirates — with the regulator's document, its version and the date we checked it.
Each of these is traced on the market page it comes from — Nigeria, South Africa and Türkiye — with the regulator's document, its version and the date we checked it.
Every bar below is a published figure from a regulator's own schedule, and every one of them is a cost that a fortnight of reading is capable of preventing. None of them is hypothetical: each is the ordinary consequence of one specific decision taken in the first two weeks of a project.
We are not claiming the assessment prevents all of these every time. It prevents each of them once, by answering the question that causes it before money is committed: what class, whose name, which list, which pathway. Three of the four have happened to companies who came to us afterwards, which is a worse way to learn it and a more expensive one.
Tick what is true — the list follows whichever product type you chose above. Nothing is sent anywhere and nothing is stored; this runs entirely in your browser. Some answers stop the assessment being worth buying, and if you tick one we will say so rather than take the money.
Tick everything that applies. Blank is a valid answer.
Reasons it usually pays for itself
Reasons to wait, or to go elsewhere
Reasons it usually pays for itself
Reasons to wait, or to go elsewhere
Tick a box on the left and this panel will tell you whether the assessment is worth your money — including when it is not.
Between eighteen and thirty pages depending on how many markets and how complicated the classification is. Written to be read by your regulatory lead and understood by your finance director.
For a device: your product against each regulator's own classification rules, with the rationale written out and the borderline calls flagged. For a medicine: which reliance, abridged or verification pathway you actually qualify for in each market, with the clause that admits you — or the one that does not.
The specific requirements, guidance documents and versions in force for your class in each market — cited by document number, not paraphrased.
Line by line: what you already hold that will be accepted, what needs reformatting, what needs translating, and what does not exist yet. This is usually the section clients photograph and send to their QA lead.
Whether the representative should be independent of your distributor in this market, what the exclusivity rules do to your options, and a shortlist of candidates with what each would charge. Where the regulator requires the holder to be locally established — as Türkiye does for medicines — the choice between a subsidiary and a partner is set out with the consequences of each.
Official fees, representative licence, translation and legalisation, testing if required, and our fee — separated, so you can see what is ours and what is the government's. For a medicine the foreign GMP inspection is its own line, because in several of these markets it is the largest one. No percentages of your revenue anywhere.
What has to happen before what, where the dependencies bite, and where the official published review period is realistic versus optimistic.
Our recommendation on order and timing — including when it is "not this market, not this year." We have written that section more than once, and clients have come back with the market that was right.
Every figure traced to the regulator's publication and the date we checked it. Where a rule is unpublished or in flux, we say so rather than quoting a number from a consultancy blog.
You get it as a PDF plus a one-hour call to go through it. The cost model comes as a spreadsheet you can drop into your own planning. If you want to see the arithmetic before you commit, the cost estimate builds the official-fee half of it live.
The process, the fee and the fortnight are the same. What we go and read is not — and neither is the section of the document that ends up mattering most to you.
The difference in one sentence. For a device the expensive mistake is usually regulatory — the wrong class, the wrong holder, a certificate nobody recognises. For a medicine it is usually commercial: a launch price you cannot move, a reference basket you did not know you were in, or a molecule on a list that means there was never a market to enter. That is why the medicines half of the document spends as much space on price as on procedure.
Two lanes run at once, and only one of them is ours. The white space in the top lane is not slack — it is where we are waiting for you, and it is the only thing that moves the delivery date.
Click a stage for what happens inside it.
What slows it down: almost always the document request. If your technical file is with a consultant who is slow to release it, tell us at the kickoff call and we will plan around it rather than promising fourteen days we cannot hold.
Fixed. One product family, up to two markets.
The full £1,450 comes off the registration project fee, which runs £12,000–25,000 per product family per market.
Paid on invoice before the kickoff call. We are not currently VAT registered, so no VAT is charged.
You do not need all of this to book. You need it to get a useful document, and part of our job is telling you which pieces you can skip.
Everything you send is covered by a mutual NDA, which we will sign before you send anything. If your legal team prefers its own template, send that instead — we do not argue about NDAs.
Then the document says so, with the reasoning, and you have saved a great deal more than £1,450. That outcome is not a failure of the assessment — it is the assessment working.
Yes. You own it outright, including the shortlist and the cost model. We would rather be chosen on the strength of the work than on you having no alternative.
We guarantee they were correct at the date on the page and traced to the regulator's own publication. Fee schedules and review periods change, and when they do we tell existing clients before they read it elsewhere.
Bring that question to the kickoff call. Roughly half of assessments end up covering a different pair of markets than the client first named, and that conversation costs nothing.
Reply by email with the product, its class or dosage form, and the markets you are weighing, and you will have a time for the kickoff call the same working day. If it is easier, WhatsApp works — a lot of our conversations with the Gulf happen there.
What applies, what it costs, what is missing and whether it is worth doing. In writing, with sources, for a fixed fee.
Each of these is set out at length, with the clause and the date we last checked it, on the market page it belongs to. Our own fees are ours to state and need no source — only a commitment, which is on the pricing page in full, including what we decline to charge for. Currency conversions on this page are indicative and were made on the date of publication.