Every one of these six regulators pauses its own review the moment it asks you a question, and restarts it when you answer. The published review period is the authority's time. The project is the authority's time plus yours — and yours is the only part anybody can actually move. That is what you are hiring.
When you ask what a registration takes, you are told the review period. Thirty-five working days in Saudi Arabia. Forty-five in the Emirates. Two hundred and forty in Nigeria. Those numbers are real, published and correctly quoted — and not one of them is a project duration.
They are the regulator's own budget for reading a complete file. In all six markets that budget is suspended the moment the authority raises a query. Nigeria writes it down in a single line: "the clock stops once compliances are issued." The Emirates put it the same way about a device — the forty-five working days assume a complete file, and a deficiency letter stops the clock. Saudi Arabia's framework says the clock pauses while your clarifications are outstanding.
So the honest equation is the authority's published period plus every day between its question and your answer. One regulator has published both halves, and the gap is the whole story.
A peer-reviewed study co-authored from inside SAHPRA found the median total approval time for a generic fell to 511 days under risk-based assessment, while the Authority's own internal assessment time ran to a median of 68–73 days. The remaining 438 days are queueing and applicant response. Under the previous regime, applicant response alone averaged 347 days against a 90-day target.
That is the lever. It is larger than the pathway you file on, larger than the fee you pay, and it is the only one a consultancy can honestly claim to pull.
We publish this because it cuts against us as much as for us: it also means a well-run project in a slow queue can still take a year, and nobody — us included — can promise you a date. What we can promise is that no day of the delay will be ours.
Pick a market and a product type. The left column is the authority's published review period. The right column is the deadline that runs against you — and in several of these markets it is the only one written down at all.
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—Read the right-hand column first. Four of these twelve cells contain a deadline that ends the application outright — not a delay, an ending, with the fee gone and the queue to rejoin. In one market the device regulation binds the authority to no period whatsoever, and binds you to ten days. Running that calendar is the single largest part of what a registration project actually is.
Roughly half of what we take on is not a clean first filing. Two of these three are rescues, and they are priced and run differently.
The market is decided, the product is approved at home, and nothing has been submitted yet. The cleanest version: we design the structure, contract the representative, build the dossier and file it.
Usually follows a route assessment, whose fee comes off this one in full.
Somebody filed, a query came back, and months have passed. Before quoting we find out where the application actually stands with the authority — which is not always what you have been told — and whether the response window is still open.
We will tell you if the honest answer is to withdraw and refile. Sometimes it is.
The authorisation exists and your distributor holds it. This is a different project from a registration and a harder one, because in some of these markets the holder cannot be changed at all and the only route is a fresh application in your own name.
Feasibility first, as a separate small piece of work. See local representation.
On taking over someone else's file. We do not open with an opinion of the previous adviser. Frequently the file was competent and the calendar was not managed — which is the whole argument of this page. What we need on day one is the submission reference, every letter the authority has sent, and permission to speak to it directly.
Six stages. The column on the right says who does it, because confusion between the four parties — you, us, the representative and the regulator — is the most common reason these projects go wrong.
Who holds the authorisation, and whether that can be kept independent of whoever sells the product. This is settled first because it is the decision that cannot be cheaply undone: Saudi Arabia wants one representative with exclusivity confirmed to the regulator, the Emirates require at least two importers by statute, and Türkiye admits only a holder established in Türkiye for a medicine.
Us, decided with youShortlist with references and real quotes, a mandate drafted so the licence stays under your control, and the appointment filed with the authority. Their fees are passed through at cost — we do not mark up a third party and we do not take a commission from one.
Us, contracted by youThe technical file for a device, or module 1 rebuilt to the market's own regional specification for a medicine, with the certificate of pharmaceutical product and the GMP certificate obtained and legalised. Legalisation is a queue, not a task: none of Egypt, Nigeria or Türkiye is a party to the Apostille Convention for these purposes, so documents go through consular legalisation and that has to sit in the calendar from the start.
You supply, we buildIn Saudi Arabia the fee is paid at submission and is not returned if the file is incomplete, which is the entire reason we do not file to hit a date. In Türkiye a medicines application cannot be filed at will at all: processes are scheduled only in February, May, August and November, against quotas, so a file that is ready in December waits.
Representative, run by usThis is the stage the fee is really for. Deficiency letters are included in the price — all of them, however many rounds — because a file that attracts no questions is rare and pricing as though it were is how surprise invoices get made. Your response windows are diarised the day the application goes in, not the day the letter arrives.
UsThe certificate, the full correspondence file, the renewal date, the post-market obligations that start on day one, and the calendar that keeps it alive. You keep all of it whether or not you continue with us.
Us, delivered to youOne fee, agreed before the work starts, split across milestones. Nothing is billed wholly in advance and nothing rolls over into a retainer.
Indicative split, fixed in the engagement letter before the first invoice. If the project stops, you pay for milestones completed and nothing further.
Per product family, per market. Devices sit at the lower end, medicines at the upper.
Official fees, representative licences, translation, legalisation, testing and inspections — invoiced at what they cost, with the receipt.
One thing we will not do at any price. We do not file a dossier we know to be incomplete in order to hit a date somebody promised a board. In Saudi Arabia that costs the fee outright; in South Africa's licensing route it costs one of your two permitted correction cycles; in most of the rest it costs the months between the query and the answer. If a deadline cannot be met honestly we will say so in writing before the engagement letter is signed.
We will give you the authority's published period, our estimate of the queue, and the response windows that run against you — as three separate numbers, because they behave differently. What we will not give you is one number presented as a date. Read the top of this page for why.
You have paid for milestones completed, and we tell you why it was refused and whether refiling is sensible. We do not charge a second full fee to correct a file we built.
Yes, and it is a third of what we do. We need the submission reference, every letter the authority has sent, and authority to deal with the regulator directly before we quote.
No. If the market is decided and the file is in reasonable shape we can quote the project directly. The assessment exists for when the decision is not made, and its fee comes off this one in full if you proceed.
You do, in your own name, wherever the market allows it — and where it does not, you know that before the project starts rather than afterwards. This is not a detail. It is the most expensive thing on the site to get wrong.
No. No royalty, no success fee, no commission from the representative or the distributor. Our fee is the fee, and it is the same whether the product sells well or not at all.
A quote takes a short call and, usually, two working days. To make it accurate rather than a range, send us the following — or as much of it as exists.
Everything you send is covered by a mutual NDA, signed before you send anything. If your legal team prefers its own template, send that — we do not argue about NDAs.
Send the product and the market. You will have a structure recommendation and a fixed quote inside two working days, with the official fees separated out so you can see what is ours and what is the government's.
What we could not confirm. No authority in these six markets publishes an average actual time to authorisation for its own files except South Africa, and that one arrives through a study rather than a regulatory publication. Every other figure on this page is a published period, not a measured outcome. Where a quoted range on this page is ours — the fee, the milestone split, the two working days to quote — it is a commercial commitment and not a regulatory fact, and it is labelled that way.
Each clock is set out in fuller context on the market page it comes from: all twelve are here.