How we work

Three stages, and you can stop after any of them

There is no bundle and no minimum commitment. Each stage is quoted and agreed before it starts, and nothing rolls into the next automatically.

Who is responsible for what

Four parties, and confusion between them is the most common reason projects go wrong. This is how we set it out in the engagement letter.

Two cells say "owner" on the same row deliberately. Post-market obligations genuinely sit on both the manufacturer and the local representative, and pretending otherwise is how incidents get reported late.

How we communicate

Confidentiality and where files live

A mutual non-disclosure agreement is signed before you send anything. If your legal team prefers its own template, we sign yours — we have no interest in arguing about NDAs, and a client who has to negotiate one before they can ask a question is a client who asks fewer questions.

Your technical documentation is shared with the local representative only to the extent the regulator requires, under the same confidentiality terms, and never with anyone else. We do not use client files as examples, we do not name clients without written permission, and we do not maintain a portfolio page for that reason.

Files are held for the duration of the engagement and for as long afterwards as the market's record-retention rules require — which in some jurisdictions runs to a decade past the last supply. On request we return everything and confirm deletion of what we are not obliged to keep.

What happens when it goes wrong

It sometimes does. These are the five failures we actually see, and what we do about each. We would rather you read this now than discover our position in the middle of it.

1. The regulator sends a deficiency letter

   The most common event, and not a failure.

   We answer it. Deficiency questions are included in the project fee — we do not treat them as a change of scope, because a file that attracts no questions is rare and pricing as though it were is how firms create surprise invoices. Where the answer requires new evidence from you, we tell you what and why, and what it does to the timeline.

2. The application is refused

   Rare, and usually foreseeable.

   We tell you the grounds, whether they are curable, and what a resubmission would cost — including the honest answer where it is not worth doing. Our fee is not contingent on approval, which is precisely why we can give you that answer straight. If a refusal traces to our error, we correct it at our cost and say so in writing.

3. The representative underperforms

   Slow, unresponsive, or out of their depth.

   We contract them, so we manage them. If it is not fixable we run the replacement, and because we keep the licence-holding entity separate from distribution, replacing a representative does not disturb whoever is selling your product. The cost of the change depends on the market — in some it is administrative, in others the authorisation itself has to be rebuilt, and the assessment tells you which before you choose.

4. The rules change mid-project

   Fee schedules, review periods, document lists, whole regulators.

   This happens more than the industry admits — one of our markets replaced its regulator and moved every service to a new portal within the last two years. We absorb the re-work into the fixed fee where it is a matter of effort. Where the change adds a new official cost or a new required document, that is passed through at cost and you see it before it is incurred.

5. You want to stop

   Mid-project, for any reason or none.

   You pay for milestones completed and nothing further. We hand over the dossier as it stands, the correspondence, the representative contacts and the shortlist, in a form another provider can pick up. There is no exit fee and no clause requiring you to explain yourself.

What we need from you

Fixed fees and fixed timelines only work if both parties hold up their end. These are the four things that actually determine whether a project runs to plan.

• A named person on your side who can answer regulatory questions and get a signature. Projects stall on approvals, not on regulators.
• Documents in one go. A partial file means we build the gap list twice, and the second build is the one that slips the timeline.
• Ten working days on our question batches. Longer is fine if you tell us — what breaks the plan is silence.
• The truth about your file. If the technical documentation was assembled by a consultant in 2019 and nobody has opened it since, say so at the kickoff call. We will find out, and finding out early is worth thousands.

Where our facts come from

Every figure we publish, and every figure in a document we give you, is traced to the regulator's own publication with the document name, its version and the date we checked it. Where an authority does not publish something openly — and several do not — we say so and confirm it directly with them, rather than repeating a plausible number from a consultancy blog.

We adopted the rule the hard way. When we verified our first two markets against primary sources, the figures circulating in the industry were wrong in both: review periods quoted at several times the published maximum, and a reliance route still being sold six years after the regulator stopped accepting applications through it. Pages are re-checked quarterly and after any circular affecting devices, and a market page does not go up until it has been checked at all.