Six things we do, and several we do not
Most people arrive needing one specific piece — a dossier rebuilt, a representative replaced, a stalled submission rescued — rather than the whole journey. Every one of these is sold on its own, each has a defined end, and nothing rolls into the next stage automatically.
- 01AssessWhich market, at what cost, and whether to go at all.Ends with a document · 1 in 5 stop here
- 02StructureWhose name the authorisation goes in.Ends when you replace us
- 03Build the fileTechnical file for a device, CTD dossier for a medicine.Ends with a file another provider can submit
- 04RegisterSubmit, and answer everything the regulator asks.Ends at the authorisation
- 05MaintainRenewals, variations, vigilance clocks.Ends every year, by itself · no auto-renewal
Which one do you actually need?
Find the sentence that sounds like your situation. It is faster than reading six service descriptions, and it is how the first conversation usually goes anyway.
What each one is
Two of these are for devices and medicines alike; two of them split by product type. All six are quoted before they start.
Route assessment
A written route for your product — device or medicine — in up to two markets: the classification opinion or the reliance pathway that admits you, what applies, the gaps in your file, a full cost model including official fees, a sequenced timeline and a verdict on whether to proceed at all.
You get
- 18–30 pages, yours to keep
- Cost model as a spreadsheet
- Shortlist of representatives with quotes
- An hour to argue with it
Right when
- The market is not yet chosen
- A deal is on the table
- Your board wants something defensible
- You want a second opinion on a quote
Local representation
Identifying, vetting and contracting the entity that will hold your regulatory licence — structured so that it is independent of whoever distributes your product. In some markets that is one representative with confirmed exclusivity; in others statute requires several importers. Getting this shape wrong is expensive and slow to undo.
You get
- Shortlist with references and quotes
- A mandate that keeps the licence yours
- The appointment filed with the regulator
- Ongoing management of it
Right when
- Entering a market for the first time
- Your representative is unresponsive
- Your distributor holds the registration
- You are entering both Gulf markets
Registration project
End to end: structure, representative, dossier, submission, and every question the regulator asks until the authorisation issues. Deficiency letters are included — a file that attracts no questions is rare, and pricing as though it were is how surprise invoices are made.
You get
- A submitted and prosecuted application
- All correspondence, in a file you keep
- Milestone billing, never wholly in advance
- Official fees at cost, with receipts
Right when
- The market decision is made
- A tender or a customer is waiting
- A previous attempt stalled
Technical file
Assembling or rebuilding the documentation a regulator will actually read: conformity against the applicable essential principles, risk management, post-market surveillance plan, clinical or performance evidence summary, labelling and instructions. Available on its own — you do not have to hire us for the registration to have us fix the file.
You get
- Gap analysis against the target market
- Rebuilt or reformatted documentation
- Translation and legalisation coordinated
- A file another provider can submit
Right when
- The file was built by someone who has gone
- You are moving between conformity routes
- A regulator has come back with questions
Registration dossier
The medicines equivalent, and a different animal. Module 1 rebuilt to each market's own regional requirements, the quality, non-clinical and clinical modules checked for what that regulator adds to what your home authority accepted, the certificate of pharmaceutical product and GMP certificate obtained and legalised, and the reliance package assembled — including the decision, which is yours, about releasing the unredacted assessment report.
You get
- Gap analysis of your CTD
- Module 1 built to that market's spec
- Legalisation and sworn translation run
- The reliance citation that admits you
Right when
- Filing abroad for the first time
- A regulator has queried the dossier
- Bioequivalence has appeared at renewal
Maintenance
The calendar that keeps an authorisation alive: renewal windows, retention fees, variations, vigilance clocks measured in hours, and requirements that change under a product already on sale. In most of these markets the way a registration is lost is not misconduct — it is a date.
You get
- A dated calendar built from the instruments
- Renewals filed to the stricter deadline
- Fees diarised and paid, with receipts
- Someone who answers the regulator in time
Right when
- Nobody is watching the deadlines
- You are not sure what you still hold
- A requirement changed and nobody told you
Two of the six have a price. Four are quoted
We are not going to invent a range for work whose scope we have not seen. A dashed bar below means exactly that — quoted after a conversation, not hidden behind a form.
Bars are proportional to the top of each range; the assessment bar is small because it is, relative to what follows it. The assessment fee comes off the project fee in full if you proceed, and a second market on the same file is £600 rather than £1,450. Official fees, representative licences, translation, legalisation and inspections are billed at cost with the receipt, never marked up. The full commercial terms — billing points, credits, currency, what we decline to charge for — are on the pricing page.
Three ways people actually buy
Almost nobody buys all six in order. These are the three shapes an engagement takes.
The full entry
First market, nothing in place
- Route assessment
- Technical file or dossier gaps closed
- Representative appointed
- Registration project
- Maintenance from year one
The file only
You have a partner, you need the file built
- Route assessment, narrowed
- Technical file or CTD dossier rebuilt
- Handed to your existing representative or provider
- We stop there, by design
The rescue
Someone else started it and it stalled
- Review of what was submitted
- Honest read on whether to continue or restart
- Takeover of the correspondence
- Registration project from where it stands
On the rescue path, one warning. Where a previous submission was made in someone else's name — a distributor's, or a provider's own entity — recovering it is sometimes not possible, and the honest answer is that you restart. We give that answer at the review stage, before you have paid for a project, because finding it out later is how a rescue becomes two failures instead of one.
What we do not do, and who does
A shorter list of capabilities that is true beats a longer one that isn't. If you need any of the following we will say so on the first call and point you somewhere — we take no referral fee for it, which is why the recommendation is worth having.
| Not us | Why | Who instead |
|---|---|---|
| Acting as your representative | The role must sit with a locally established, licensed entity | We appoint and manage one for you |
| Conformity assessment or certification | That is a notified or approved body, and it must be independent of whoever prepared the file | An EU notified body or UK approved body |
| Laboratory testing | Requires accreditation we do not hold | An accredited test house; we coordinate and pass through at cost |
| Clinical investigations | A specialist discipline with its own regulatory track | A CRO; we can specify what evidence the market needs |
| Bioequivalence studies | Run at authorised centres under their own accreditation, and in some markets at centres the regulator licenses individually | A CRO; we establish which centres the target regulator will accept, and where it publishes no list we say so |
| Holding a marketing authorisation for you | Several of these markets require the holder to be established locally — Türkiye admits only applicants established in Türkiye | Your subsidiary or your partner; we set out the consequences of each before you choose |
| Finding you a distributor | A commercial search, and mixing it with regulatory work creates a conflict about who holds the licence | A commercial agent; we keep the regulatory structure independent of whoever you choose |
Where each service stops
Every one of the six has a defined end. That is deliberate.
- The assessment ends with a document. Roughly one in five clients stops there, and the document is theirs.
- The technical file, and the dossier, end with a file — in a form another provider can submit. We do not need to be the ones who submit it.
- Representation ends when you replace us or the appointment is transferred. No notice period beyond what the regulator requires.
- A registration project ends at the authorisation, or at the point you decide to stop, with everything handed over.
- Maintenance ends every year on its own. It does not auto-renew — we ask, and sometimes the answer is no.
- Nothing rolls into the next stage automatically, and you own every document we produce, including if you take it elsewhere.
Not sure which one applies?
Describe the situation in two lines and we will tell you which service fits — including when the answer is that you do not need us yet.