Dossier Licensing & Product Registration
In-licensing and out-licensing of CTD and ACTD dossiers, with the regulatory and intellectual-property groundwork done before you commit capital — not after.
The mistake that costs the most money
The single most expensive error we see in this business is a buyer selecting a product and beginning to invest — dossier fee, registration fee, sample batches, launch planning — before establishing the intellectual property position in the market they actually intend to sell in.
Patent status is not global. It is country by country, and the differences are large enough to decide whether a project is viable at all. Semaglutide is the clearest current example: it is off patent in a number of ROW markets while remaining protected in the European Union until around 2030. A buyer who reads a headline about expiry and plans a European launch on that basis has lost their money before they started.
A freedom-to-operate assessment for the specific target market, taken before commitment, is cheaper than any of the alternatives. We insist on it as the first step.
Check before you invest
- Compound patent expiry in your target country
- Secondary patents — salt, polymorph, formulation, process
- Data and market exclusivity periods, which run separately from patents
- Supplementary protection or term extensions
- Pending divisional applications
- Whether the dossier's bioequivalence reference is accepted locally
Choosing the dossier format
Acquiring a dossier in the wrong format for your target regulator means paying twice — once for the dossier and again to restructure it. This is the comparison we work through with clients first.
| Format | Broadly used in | Practical notes |
|---|---|---|
| CTD / eCTD | EU, UK, US, Canada, Australia, Japan, Switzerland, and increasingly adopted across the Gulf, Africa and Latin America | The ICH Common Technical Document, five modules. The most portable starting point, and generally the easiest to adapt downwards to national formats. |
| ACTD | ASEAN member states | The ASEAN Common Technical Dossier, four parts. Overlaps substantially with CTD but the administrative and quality sections are arranged differently, so conversion work is real but manageable. |
| National / country-specific | Many individual ROW markets | Some regulators still maintain their own structure and their own additional requirements — local stability data in the applicable climatic zone, local labelling, or country-specific legalisation of supporting certificates. |
Regulatory requirements change. We confirm the current accepted format and requirement set with the relevant authority for your specific market at the start of every project rather than relying on what was true last year.
Licensing structures we work with
Dossier licence
Right to register and market the product in a defined territory using the owner's dossier. Supply usually remains with the dossier owner. Fastest route to market where you have distribution but no manufacturing.
Dossier sale / assignment
Outright transfer of the dossier for a territory, giving you freedom to change manufacturing site later. Higher upfront cost, more control, and a technology transfer to plan for.
Licence plus supply
The common ROW structure: you hold the marketing authorisation in your name, the partner manufactures and supplies. Price mechanism, MOQ and exclusivity are the terms that matter most here.
Out-licensing your dossier
If you hold dossiers with unused territories, we can position them with buyers in markets you are not addressing yourself — without disclosing your identity until terms are broadly agreed.
How we run a licensing project
Before anything else: what is the patent and exclusivity position in the country you intend to sell in? If it does not clear, we say so and the project stops there rather than after you have paid a dossier fee.
Accepted dossier format, whether local bioequivalence or local stability data is required, climatic zone, reference product acceptability, and realistic review timelines for that authority.
We identify available dossiers and assess them against your market's requirements — not just whether a dossier exists, but what is missing from it and what closing that gap will cost in time and money.
Upfront, milestones, royalty or transfer price, territory definition, exclusivity, term, minimum purchase obligations and the consequences of missing them. Weak territory and exclusivity drafting causes most later disputes.
Dossier compilation or conversion, CoPP and legalisation chain, agent appointment where a local marketing authorisation holder is required, and query response support through the review.
Variations, renewals, site changes and the pharmacovigilance obligations attached to holding an authorisation — which buyers routinely underestimate at the point of signing.
Two things buyers get wrong about price
Capacity utilisation drives your quote
A manufacturer's price is heavily influenced by how full their line already is. The same product, from the same site, quotes differently depending on whether your volume fills spare capacity or displaces existing work. Buyers who present a credible annual forecast and a realistic delivery schedule consistently get better pricing than buyers who ask for a spot price on an indefinite quantity. This is not negotiation technique; it is how the cost genuinely behaves.
Product selection beats price negotiation
Most of the margin in a portfolio decision is made at selection, not at negotiation. A well-chosen product in a market with a clear regulatory path and manageable competition will out-earn a hard-negotiated price on a crowded molecule. We would rather spend the first conversation on whether the product is right than on shaving the quote.
Who we work with
- Generic companies building or filling a portfolio in a new territory
- Distributors and importers moving up the value chain into own-label registration
- Manufacturers with dossiers whose territories are unused and monetisable
- Regional players entering ASEAN, the Gulf, Africa or Latin America for the first time
- Investors assessing whether a portfolio's regulatory assumptions actually hold
Tell us the molecule and the market
We will come back on the IP position, the accepted dossier format and whether the project is realistic — before you spend anything.
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Frequently Asked Questions
This page describes commercial and regulatory support services. It is general information about regulatory and intellectual-property processes, not legal advice. Patent, exclusivity and registration positions should be confirmed with qualified local counsel and the relevant authority before you commit funds.
