For medical devices and for medicines, in six markets. Published because the alternative — "contact us for a quote" — is how this industry keeps buyers from comparing. Every figure below is either our fee, which is fixed, or a regulator's published fee, which we pass through at cost with the receipt.
You are quoted a number before the work starts and that number is what you pay. If we misjudge the effort, that is our problem — which is the correct incentive for the person doing the scoping.
Regulator fees, representative licences and legalisation are billed exactly as paid, with the receipt attached. We do not mark them up, and we do not bundle them into a round number that hides the margin.
No percentage of your sales, no success fee, no commission from a distributor for introducing you. Our income does not change with who you appoint or how much you sell.
Why the third rule matters more than it sounds. A success fee sounds fair until you notice what it rewards: submitting the file before it is ready, because the fee only lands on approval. In regulatory work the person preparing the dossier must be paid the same whether or not the answer is "wait." That is why we take a fixed fee and no upside.
One product family, up to two markets. Written route, gap list, cost model and a verdict. Credited in full against the project if you proceed.
Per product family, per market, device or medicine. Representative appointment, dossier assembly, submission and every regulator question through to authorisation.
Per market, per year. Renewals, variations, added products, import permits, reporting deadlines and a quarterly regulatory change note.
Additional products added to an existing registration are quoted individually and are always a fraction of the first — the licences, the representative and the relationship already exist.
The cost estimate assembles the lines below — the regulator's published fees for your class, our fixed band for your market, and the third-party costs marked as estimates — into one sheet you can print or send. It will not guess at a budget for a market whose fee schedule we have not yet verified, and it says so on the page.
These are published by the authorities and paid to them. We show them because a quote that does not separate them is hiding something.
| Saudi Arabia — SFDA | Fee |
|---|---|
| Marketing authorisation, Class A | SAR 15,000 |
| Marketing authorisation, Class B | SAR 19,000 |
| Marketing authorisation, Class C | SAR 21,000 |
| Marketing authorisation, Class D | SAR 23,000 |
| Renewal | SAR 5,000 |
| Label, IFU or advertising update | SAR 1,100 |
| Authorised representative licence | SAR 2,600 / year |
| United Arab Emirates — EDE | Fee |
|---|---|
| Device marketing authorisation | AED 100 + 5,000 |
| Renewal | AED 100 + 2,500 |
| Product classification determination | AED 500 |
| Manufacturing site registration, renewal | AED 100 + 10,000 |
| Medical warehouse licence | AED 7,500 + inspections |
| Import permit | AED 100 + 1% of CIF |
Checked against the regulators' published schedules in August 2026. Saudi figures come from a dated fee sheet; the Emirati pages carry no publication date, so we re-confirm them with the authority before they enter a quote. Currency is converted at the rate on the date of payment, and we invoice you the actual amount paid.
A different set of authorities, a different shape of cost. The registration fee stops being the big number.
| United Arab Emirates — EDE | Fee |
|---|---|
| Marketing authorisation, conventional or biological medicine | AED 7,000 |
| Marketing authorisation, general sales list or natural source | AED 5,000 |
| Renewal, conventional or biological | AED 3,500 |
| Variation | AED 1,000 |
| Laboratory analysis | AED 3,000 |
| Pharmacovigilance plan evaluation | AED 1,000 |
| Pricing certificate, single product | AED 500 |
| Manufacturing site registration or renewal | AED 10,000 |
| Good manufacturing practice certificate | AED 2,000 per line, per year |
| Nigeria — NAFDAC | Fee |
|---|---|
| Registration, prescription medicine | US$1,200–1,280 |
| Registration, over-the-counter medicine | US$967 |
| Renewal | 80% of the registration fee |
| Foreign GMP inspection, per site | US$10,989 |
| Desk review where the site has already been inspected | US$5,000 |
| Türkiye — TİTCK | Fee |
|---|---|
| Application, new molecule or reference product | ₺816,512 |
| Application, generic | ₺489,908 |
| Renewal | ₺24,360 |
| Variation, type IA · IB · II | ₺5,174 · 12,318 · 24,360 |
| Foreign GMP inspection, first time, one site and one product | ≈ ₺1,785,375 |
In Nigeria a foreign site inspection costs roughly nine times the registration fee it accompanies. In Türkiye it costs roughly twice a new-molecule application. Neither number appears in a quote that lists only "registration fees", and neither is avoidable on first entry — the relief is either a reliance route that accepts your existing GMP certificate, or a second product filed behind the same inspection. Which of those is open to you is a question with a documented answer, and it belongs in the assessment rather than in a surprise invoice.
Emirati figures from EDE's published service catalogue; Nigerian from the NAFDAC tariff effective 31 January 2020, which is still the only one NAFDAC publishes; Turkish from the TİTCK tariff of 23 March 2026, which is reissued during the year. Egypt publishes no medicine fee schedule at all — amounts appear only as figures embedded in guideline prose. South Africa publishes its fee regulation as a scanned image with no readable text layer, so we hold the gazette citation and not the numbers. Where we cannot cite a figure we leave the line empty rather than borrow one, and we confirm it with the authority during the assessment.
Third-party costs that are neither ours nor the regulator's: translation into Arabic, notarisation and embassy legalisation, sample shipping, and testing where a market requires it. We estimate these in the assessment and pass them through at cost. Legalisation in particular has its own queue and is the most common cause of a delayed Emirati file.
Three worked examples: two devices and one medicine. Our fees in sterling, official fees in local currency, third-party costs marked as estimates.
| Saudi Arabia, year one | Amount |
|---|---|
| Route assessment | £1,450 credited |
| Registration project, our fee | £12,000–16,000 |
| SFDA marketing authorisation, Class B | SAR 19,000 |
| Representative licence, first year | SAR 2,600 |
| Translation, notarisation, legalisation estimate | £1,500–4,000 |
| Our fee, net of the credited assessment | £12,000–16,000 |
| Paid to SFDA | SAR 21,600 |
| United Arab Emirates, year one | Amount |
|---|---|
| Route assessment, second market on the same file | £600 credited |
| Registration project, our fee | £12,000–18,000 |
| EDE device marketing authorisation | AED 5,100 |
| Manufacturing site registration | AED 10,100 |
| Classification determination, if required | AED 500 |
| Embassy legalisation of free sale certificate estimate | £800–2,500 |
| Our fee, net of the credited assessment | £12,000–18,000 |
| Paid to EDE | AED 15,700 |
The Emirati project sits higher in the range than the Saudi one for a reason that has nothing to do with paperwork volume: statute requires at least two licensed importers, so the structure has to be designed and contracted rather than simply appointed. Warehouse licensing is normally borne by the licensed establishment itself; where it is recharged, it appears on your invoice at cost.
| United Arab Emirates, year one | Amount |
|---|---|
| Route assessment | £1,450 credited |
| Registration project, our fee | £14,000–20,000 |
| EDE marketing authorisation, conventional medicine | AED 7,000 |
| Manufacturing site registration | AED 10,000 |
| Good manufacturing practice certificate, one line | AED 2,000 |
| Laboratory analysis | AED 3,000 |
| Pharmacovigilance plan evaluation | AED 1,000 |
| Pricing certificate | AED 500 |
| Certificate of pharmaceutical product, legalisation and sworn translation estimate | £1,200–3,500 |
| Our fee, net of the credited assessment | £14,000–20,000 |
| Paid to EDE | AED 23,500 |
The medicine sits above the device on the same regulator for three reasons, all of them work rather than markup: module 1 of the dossier has to be rebuilt to the Emirati regional specification, the certificate of pharmaceutical product has to be obtained and legalised in the country of manufacture, and the pricing submission is a separate exercise from the authorisation. The two-importer requirement applies to both. Note what is not in this table: Emirati medicine pricing is set against a reference-country list that exists in statute and is published nowhere, so a price cannot be modelled from public sources — that is stated plainly on the market page rather than papered over with an estimate.
For a device, higher classes carry more evidence and, in some markets, additional safety and efficacy requirements. For a medicine the equivalent split is generic against new molecule against biological, and it moves the regulator's own fee as much as ours.
A current CE or FDA file that only needs reformatting sits at the bottom of the range. A file assembled years ago by a consultant who has since disappeared sits at the top.
One device is a project. Fourteen SKUs across three configurations is a different project, and it is cheaper per SKU but not per project.
Where statute requires multiple importers, or where you already have a distributor whose contract must be unpicked, the commercial design takes real time.
A device with a 60-page instruction manual for lay users costs materially more than a professional-use device with a two-page insert.
Medicines only. Where a reliance route accepts your existing GMP certificate, a five-figure foreign inspection disappears from the budget. Where it does not, it is usually the largest line in it.
Medicines only, and it is a legal decision rather than a regulatory one. Releasing the unredacted assessment report from your home authority moves you onto lighter review in more than one of these markets.
The cheapest projects are the ones where the assessment found few gaps. That is the actual argument for doing the assessment first.
Assessment invoiced before the kickoff call. Projects billed at agreed milestones, never wholly in advance. Maintenance annually, and it does not auto-renew — we ask you each year, which occasionally produces the answer "no" and that is fine.
We are not currently registered for VAT, so no VAT is charged on our fees. That will change when we cross the threshold, and existing clients will be told before it appears on an invoice.
The first market is expensive and every one after it is cheaper — but not for the reason people expect. The saving is not a volume discount. It is that the licences, the structure, the representative relationship and the rebuilt file already exist.
| What you are adding | Paid again | Not paid again |
|---|---|---|
| Second market, same product | Full project fee for that market, plus that regulator's own fees | The assessment for it, if bought together at £600 rather than £1,450; and the technical file work, which is done once |
| Second product, same market, same class | A reduced project fee and the regulator's product fee | Representative licensing, structure design, and the market groundwork |
| Variants and SKUs on an existing authorisation | Quoted individually, normally a fraction of the first | Almost everything else |
| Renewal when the term expires | The regulator's renewal fee, which is a fraction of the original | The whole registration — provided nobody let it lapse |
This is why the sequencing conversation in the assessment matters more than the fee negotiation. Choosing the right first market decides what everything after it costs.
Nobody publishes this one, and it is usually larger than the fee being negotiated.
Not that £1,450 is cheap. That the three failures above are all decided in the first two weeks of a project — by the classification, the sequencing and whose name goes on the file — and all three are cheaper to get right than to unwind.
Prevailing rates for regulatory consulting run roughly $135–175 an hour for an associate, $250–300 for mid-level and $340–400 for senior work. Those are market figures rather than ours, and we quote them because they make the fixed fee legible: at the middle of that band, £14,000 is somewhere around fifty hours of senior time.
A first-market registration is more than fifty hours. Classification and its defence, structure design, finding and vetting a representative, contracting them properly, assembling a dossier to a format you have not used before, and answering deficiency questions in a second language — that is a project, not a task. A fixed fee is our bet that we have scoped it correctly, and if we are wrong the loss is ours.
Doing it in-house is not primarily a question of hours, though. It is that your regulatory manager will be learning that market on your fee schedule, and the regulator does not refund the fee when the learning shows up in the file.
The honest exception. If you already have a regulatory team that has registered in this market before, you probably do not need us for the registration at all — you may only need the representative found and contracted properly. Say so on the first call and we will quote that alone. It is a much smaller number, and we would rather have the smaller engagement than sell you the larger one.
Because the difference between a clean file and an incomplete one is genuinely six figures of effort over a portfolio — whether that file is a CE technical file or a common technical document. The assessment closes the range to a fixed number before you commit to anything.
Yes. That is a route assessment with a narrower brief, at the same fee. We will tell you plainly if the quote you hold is reasonable — sometimes it is, and we say so.
The official fee changes and we invoice the new amount at cost. Our fee does not move — that is what fixed means.
Our fee, modestly — the dossier work is heavier. The regulator's fee, sometimes by an order of magnitude, and almost always because of the foreign GMP inspection rather than the registration itself. The assessment separates the two before you commit.
Yes, on the assessment: £600 per additional market rather than £1,450. On registration projects the saving is real but smaller, because each market is a separate submission to a separate authority.
Not our fee — the total. Two weeks and £1,450 gets you every line above filled in for your product, its class or pathway, and your markets.
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