A tenth to a third of a medicine’s value is never collected.
It sits outside the United States, Western Europe and Japan, where registering a product and standing up a commercial operation costs the same whether the territory returns fifteen million dollars or five hundred. We run that work with agents, so a launch is limited by the regulator’s clock and not by headcount.
Commercial value in this industry concentrates in three markets: the United States, Western Europe and Japan. Everywhere else is the fastest-growing part of the industry — $350bn in 2024, reaching $550bn by 2030, compounding at roughly 10% a year against 6% in developed markets — and for most originators it is simply unsold.
Latin America, the Middle East and Southeast Asia. That is where we work.
An approval does not travel on its own. Hundreds of medicines cleared by the FDA or the EMA have no licensee anywhere in those three regions. The science is not in question: it is the same molecule, already approved. What stops it is that the cost of entry barely moves with the size of the prize, so the smaller territory never clears the internal bar.
So the footprint never gets built. We build it. We take commercial rights from the originator, own the local entity, hold the registration in our own name and carry the compliance obligations that come with selling there. Physical distribution is contracted to licensed local partners. We do not run trials and we do not develop: clinical risk stays with you.
Agencies stopped repeating the FDA’s work.
The WHO formalised Good Reliance Practices in 2021 and national agencies have built on it since. Saudi Arabia’s verification and abridged routes let a company file straight after FDA or EMA approval. The Gulf runs one submission across member states. Mexico replaced a decade of one-off bilateral agreements with a single abbreviated route recognising any reference authority, in force since September 2025. On the fastest of these routes a clearance takes about two months. What is left of a submission is translation, reformatting and local adaptation.
Regulatory bridging is no longer expensive.
Converting a dossier into a compliant local submission used to mean regulatory writers working module by module, repeated for every product and every country. We run that layer with purpose-built agents: dossier conversion into local eCTD format, labeling in Arabic, Portuguese and Spanish, safety case intake, pricing and HTA submissions, agency queries. The same layer carries the obligations that never end — renewals, variations, pharmacovigilance — which is the part a biotech cannot absorb fifteen times over. Our people do only the work that structurally needs a person in the room: the national qualified person, the managers who sit with hospital formulary committees, the medical science liaisons.
Where else could your drug make a difference?
Tell us what you hold and where you don’t plan on launching yourself. We come back with the markets worth entering, the registration route each one allows, and what it takes to launch there. We are paid out of what the medicine earns in the territory, so there is nothing to pay for the assessment.
Talk to us about your asset →We work with medicines approved by the FDA or the EMA, and with Phase III assets approaching approval.