Approved in one market.Absent from the rest.
A launch plan pays for the United States, Western Europe and Japan. Registering, pricing and standing up a commercial operation costs the same months in a market worth two hundred million and a market worth two. So the medicine never arrives, the tenth to third of its lifetime value that sits outside the core is written off, and an approval you already hold earns nothing there.
firstocean does that work once, across the markets we cover, in parallel. That is what makes a smaller territory worth entering.
One approval. A sequence, not a separate build in every market.
None of this was possible five years ago. Since the WHO formalised Good Reliance Practices in 2021, regulators across Latin America, the Middle East and Southeast Asia can rely on a dossier the FDA or the EMA has already assessed rather than repeating the review. On the fastest of those routes a medicine already approved in the US or Europe can be cleared in about two months.
Price does not follow the same map. Many countries set price against a basket, so the wrong first launch drags the price in markets you already care about.
We sequence both.
Recognition
30 to 60 working days
Saudi Arabia's SFDA verifies or abridges an existing FDA or EMA approval instead of reviewing it again.
Abbreviated review
In force since September 2025
Mexico's COFEPRIS recognises any reference authority, replacing a decade of one-off bilateral agreements.
Cluster review
One submission, several countries
Gulf centralised review. ASEAN common technical dossier. Format is shared; decisions are still national.
Regional reference
One approval carries
Latin American regulators rely on a PAHO reference authority: ANVISA, COFEPRIS, INVIMA.
We become the licence holder.
firstocean owns an entity in each market, takes commercial rights from you and files the registration in its own name. From then on the obligations of selling there sit with us: renewals, variations, pharmacovigilance, the qualified person the regulator requires on the ground. Your regulatory team does not acquire fifteen new jurisdictions.
The work behind that runs on purpose-built agents — dossier conversion into local format, labelling, pricing and HTA submissions, agency queries — and our people do only what structurally needs a person in the room. That is the reason a territory returning fifteen million dollars is worth entering at all.
We are paid out of what the medicine earns in the territory. No retainer, no fee for the assessment, and nothing at all until it is on the market. We do not run trials and we do not develop: clinical risk stays where it is.
You decide where it goes.
- Territories.
- We enter nothing without your approval. A market you want held back stays held back.
- Reference price.
- We set price in each territory against your existing markets, so a launch here does not drag a price down there.
- One counterpart.
- One contract and one reporting line covering every market we run, instead of a separate licensee, agreement and report in each.
Move product in these markets?
We contract licensed distributors across Latin America, the Middle East and Southeast Asia to warehouse and deliver the medicines we register and sell. We hold the licence and carry the compliance; you move the product.
Start with one asset.
Tell us what you hold and which territories you have no plans for. We come back with the markets worth entering, the registration route each one allows, and what it takes to launch.
Or estimate the value outside your core markets →
We work with medicines approved by the FDA or the EMA, and with Phase III assets approaching approval.