A technical file built for the EU and a dossier built for the MHRA are both perfectly good documents. They are also built around a certificate that four of these six markets do not name, and they are missing documents that have to be obtained abroad, translated, and legalised through a consulate. That gap is the work.
A manufacturer who moved from CE to UKCA did not simply swap one certificate for another. In markets whose document lists were written to rely on a CE certificate, they deleted the item the whole file was designed to sit on — and most of those lists have not been rewritten since.
The Emirates ask for a quality conformity certificate and name three: EC, 510(k), PMA. UKCA is not among them, and we have found no published instrument saying it will do. Türkiye's device regulations contain the string "UKCA" zero times — we searched the consolidated texts. Saudi Arabia shortens nothing for any foreign approval, so the question does not arise there. Egypt is the exception, and a striking one: it names the United Kingdom on its reference-country list and publishes a dedicated instrument for devices marketed in Great Britain and not required to be marketed in the EU.
Saudi Arabia has stopped asking for a certificate of pharmaceutical product — in SFDA's own words, it "is optional and no longer required for new Marketing Authorization applications within all regulatory pathways". Egypt, Türkiye, Nigeria and the UAE all still require one, and Nigeria wants it authenticated by its own High Commission.
Which means a dossier assembled for one of these markets is not portable to the next, and the item you can safely delete in one is the item that blocks you in another.
This is why we do this work as its own service rather than only as part of a registration. Quite often the file is the project, and everything else is waiting on it.
The left column is what goes in. The right column is what is conspicuously absent from the published list, which is usually the more useful half.
A document that has to be authenticated by a foreign mission is not a line item you tick in an afternoon. It is a third party's calendar, in a third country, and it sits on the critical path of everything downstream. Three of these six markets have no apostille route at all.
Where a cell says "not traced", that is a statement about our research, not about the market. It means we have not found the rule in a regulator's own publication and will not repeat one from a secondary source.
Reliance pathways run on the report your home regulator wrote about you. Two of these markets make the commercial consequence explicit, and the choice belongs to you rather than to your regulatory adviser.
How we handle it. We put the trade-off in writing with the clause that creates it, we price both paths, and then you decide. We do not release an assessment report on your behalf without a written instruction, and we do not treat the decision as a formality because it is the one item in a dossier that is a business judgement rather than a regulatory one.
The gap analysis is sold on its own and is frequently all anyone needs. Nobody is obliged to buy the rebuild from the people who found the gaps.
Your file, line by line, against the published requirement for that market and that class or pathway. Three columns: accepted as it stands, needs reformatting or translating, does not exist yet. Delivered as a document you can hand to your QA lead or to another provider.
Us · sold separatelyCertificates of free sale, certificates of pharmaceutical product, GMP certificates, manufacturing licences — requested from the right authority, which for a medicine is the authority where the product is made rather than where it is authorised. This is where the legalisation queue starts, so it starts first.
Us, with your QAFor a device: conformity against the applicable essential principles, the risk management file, post-market surveillance plan, clinical or performance evidence summary, labelling and instructions for use, and the UDI carrier where one is required. For a medicine: module 1 rebuilt to that market's own regional specification, and the quality, non-clinical and clinical modules checked for what that regulator adds to what your home authority accepted.
UsSworn translation where the market requires it — Türkiye requires it for the representative's mandate and for the instructions for use loaded into ÜTS. Legalisation coordinated through the right mission. You receive a submittable file, whether or not we are the ones who submit it.
Us, coordinatedAvailable without the registration. You do not have to hire us for the project to have us fix the file. A file we build is a file another provider can submit, and we write it to be readable by someone who was not in the room.
Sometimes the gap analysis finds that the evidence a market requires was never generated, and that no amount of formatting will close it. When that happens we say so in the gap analysis rather than building three months of documentation around an absence. It is the shortest version of this engagement and the one clients thank us for later.
Usually yes, and it is the fastest way to start. A table of contents plus the class or dosage form tells us most of what drives the scope.
Common, and worth saying at the first call. We plan around it rather than promising a date we cannot hold, and the gap analysis can often start from the index and the certificates while the rest arrives.
In one of these six it is an advantage, because Egypt publishes an instrument specifically for devices marketed in Great Britain. Elsewhere it ranges from neutral to a problem that needs establishing in writing with the regulator before you spend money. That answer is per market, and it is the first thing a gap analysis resolves.
Yes, and we do it often. The deliverable is a document, not a relationship, and we are happy for it to land on someone else's desk.
Usually one to two weeks depending on how many markets and how much of the file exists. The obtaining and legalising stage is the long one, and its length is not ours to set.
We keep what we need to support you, under the NDA, and we delete on request. You own the output outright.
Do not send us three hundred megabytes to begin with. The table of contents, the certificates you hold and the market you are aiming at are enough to scope the work and quote it.
Mutual NDA signed before you send anything. If your legal team prefers its own template, send that instead.
A gap analysis costs a fraction of a registration project and occasionally replaces one. It is also the only part of this work that gets cheaper the earlier you do it.
What we could not confirm. We have not traced a legalisation requirement for the Saudi device file or the South African device licensing pack to a regulator's own publication, and we do not infer one from either country's treaty position — the table above says "not traced" rather than "none required". We have also found no published instrument confirming that a UKCA certificate satisfies the Emirati quality conformity certificate requirement, and we will not state that it does on the strength of a secondary source.
Each document list sits in fuller context on the market page it comes from: all twelve are here.