Is registration always the right route?

No. For some categories a non-registered model reaches performance, education and research buyers immediately, while registration opens the clinical segment on a much longer calendar. For a rehabilitation-technology client this was the entire strategic question — not whether to enter, but which of the two doors to use first.

How long does approval actually take?

It varies by classification more than by country, and the published timetable is rarely the working one. We give you a dated calendar with the parallel paths marked, and we say which dates we are confident about and which we are not.

Can you file on our behalf?

No, and we would be wary of anyone who both advises on the route and profits from the filing. We identify, qualify and negotiate with the registration and importation partners; you contract with them directly.

What about the rare disease catalogue in China?

Inclusion in the national catalogue is a separate procedural process with its own route, its own eligibility rules, and its own submission windows. It usually requires a Chinese organisation to carry the file. We have run that process; see the GRIN-NDD case.

Does this cover Europe as well as China?

Yes. CE marking, the MDR and IVDR technical file, authorised representative and notified-body selection, and the country-by-country reimbursement question that follows. Europe is twenty-seven reimbursement systems behind one approval.

Service · both directions

Approval clears one gate out of eight.

Most companies arrive believing registration is the hard part. It is the second of eight gates, and the two where entries actually fail come later. This engagement establishes which regime applies to your product, what the realistic calendar is, and what has to be true after approval for approval to turn into revenue.

Book a 30-minute discussion Request the procurement pack

Engage us for this if

You do not know which classification or regime your product falls under
You are choosing between registering and staying outside registration
Your calendar assumes approval equals market access, and you want that tested
You are entering Europe from China and need CE, MDR or IVDR read properly

This is not the right engagement if

You need a registration agent to file on your behalf — we identify and qualify them, we are not one
You want a regulatory opinion with legal liability attached
Your product is already registered and selling, and the question is commercial

What you get

Named deliverables, not a scope of intent.

Classification and applicable regime, with the texts behind the conclusion
The registration route, its evidence requirements, and where a trial waiver is possible
A dated calendar, including the steps that run in parallel and the ones that cannot
Registered versus non-registered comparison — and which segments each model can actually reach
The eight gates mapped against your product, with the two most likely to fail named
Identification and qualification of registration, importation and in-country partners

Why this is hard

Planning against the wrong regime is the most expensive mistake in the file
Classification decides the dossier, the calendar and the cost, and the answer is rarely on the first page of the guidance. It is also the mistake nobody notices for a year.
The published timetable is not the calendar
Approval arriving eleven months after the plan said it would is not a delay. It is a budget cycle, a launch window and, often, a sponsor.
Registered or not registered is a commercial decision disguised as a regulatory one
Each answer opens some segments and closes others. Treating it as a purely regulatory question is how companies end up approved and unsellable.
Approval is the third gate, not the last
Importation route, distribution, pricing and reimbursement come after it, and that is where entries with a perfectly valid registration still fail.

Duration. Typically four to eight weeks for an assessment; longer where a partner search is attached.

What this costs

€15,000 – €35,000, depending on how many products and how many regimes are in scope.

Why we publish it

Because you need to know which internal approval route to open before you spend half an hour finding out. A range is not a quote, and nobody has ever been offended by a range. Yours is quoted line by line — named people, day counts — so you can remove anything you do not want.

What you can hold us to

You always know who pays us

Some engagements are fee-only; business development can carry success-linked compensation. Whichever applies, the structure is agreed with you in writing before the work starts and it is in the Scope of Work.

Priced before you commit

A detailed, line-by-line quote — named people, day rates, day counts — so you can remove anything you do not want and benchmark what is left.

A partner replies, not a salesperson

The partner who scopes the work is the partner who does it. Expect an answer within two working days.

All three appear in every Scope of Work. If we are not the right firm for the question, we say so — and, where we can, say who is.

Who leads this

Eric Bouteiller

Executive Partner · Co-founder

A pharmaceutical executive in China and Asia, with three decades of industry-association and academic work across the region — and one of the few French executives who reads, writes and negotiates in Chinese.

Full profile

This work, already done

ECS Progastrin · Diagnostics · oncology biomarker

Finding the fastest legitimate route for a cancer-screening biomarker

A fast-track regulatory plan for the hPg80 biomarker, a Taiwan-first sequence, and clinical collaboration with Chinese oncologists.

Read the case → HRA Pharma · Pharmaceuticals · rare disease

Entering China without draining a small company

Policy mapping, pricing and promotion design, supplier selection and negotiation — with our people on the ground at the stages that mattered.

Read the case → GRIN-NDD · with Alira Health · Rare disease · policy and access

A fast-track dossier for China’s rare disease catalogue

Two weeks to confirm the submission route, assemble the disease evidence package and coordinate an eligible Chinese sponsoring organisation.

Read the case → More engagements

Nine case studies, described in full

What was asked, what we did, what it produced, and what it taught us.

All case studies →

What people ask us

Is registration always the right route?: No. For some categories a non-registered model reaches performance, education and research buyers immediately, while registration opens the clinical segment on a much longer calendar. For a rehabilitation-technology client this was the entire strategic question — not whether to enter, but which of the two doors to use first.
How long does approval actually take?: It varies by classification more than by country, and the published timetable is rarely the working one. We give you a dated calendar with the parallel paths marked, and we say which dates we are confident about and which we are not.
Can you file on our behalf?: No, and we would be wary of anyone who both advises on the route and profits from the filing. We identify, qualify and negotiate with the registration and importation partners; you contract with them directly.
What about the rare disease catalogue in China?: Inclusion in the national catalogue is a separate procedural process with its own route, its own eligibility rules, and its own submission windows. It usually requires a Chinese organisation to carry the file. We have run that process; see the GRIN-NDD case.
Does this cover Europe as well as China?: Yes. CE marking, the MDR and IVDR technical file, authorised representative and notified-body selection, and the country-by-country reimbursement question that follows. Europe is twenty-seven reimbursement systems behind one approval.

The next step

Get your pathway assessed.

Tell us the market, the product and the decision in front of you. A partner replies within two working days with either a scoped, line-by-line quote — or the reason we are not the right firm for it.