The incremental revenue looks close to free compared with what it cost to get this far. Then someone points out that the ERP has one legal entity, one currency, and one time zone in it.
The US approval is in hand or close to it, and someone has run the numbers on Europe. The therapy is the same, the dossier is largely built, and the incremental revenue looks close to free compared with what it cost to get this far.
Then your controller points out that the ERP has one legal entity in it, one currency, one chart of accounts, and a close process that assumes everybody is in the same time zone. And your quality lead mentions Annex 11.
It is architecture. Multi-entity, multi-currency, and multi-jurisdiction reporting are design decisions. Retrofitting them into a live system with two years of transactions in it means a data migration, a revalidation, and a close you cannot run for a month.
The regulatory design gets done twice. A US-only quality system gets built, then an EU-facing one gets bolted alongside it, and the company maintains two sets of documentation describing one set of processes. The convergence between FDA's CSA thinking and the revised Annex 11 makes this avoidable — you can build once and present twice — but only if the decision is made deliberately.
Nobody owns the operating model. Regulatory owns the filing. Commercial owns the launch. Finance owns the entity. The connective tissue — how a European order becomes cash, who releases product, which system holds the master data — is everybody's and therefore nobody's.
Operations. Order-to-cash, distribution, and returns should work the same way with different parameters, rather than becoming a second business that happens to sell the same product.
Regulatory. A single validated baseline that satisfies both regimes, with the deltas documented rather than duplicated. Where Annex 11 asks for something FDA does not, that is a delta — not a second system.
Capital. Intercompany, transfer pricing, and consolidation designed before the second entity exists. If you are also heading toward a filing, this is the same work. Do it once.
Global. Statutory reporting, local VAT, local language where required, and a close calendar that accounts for the fact that your two finance teams do not overlap for most of the working day.
We look at what your current systems actually support versus what they are assumed to support — those are usually different — and at what your EU plan implies operationally rather than regulatorily.
Then a written position on what has to change, what it costs, and the order to do it in.
Most of these decisions are cheap if made before the entity exists and expensive after. Knowing which ones, and in what order, is the whole value of doing this early.
Often a targeted analysis on the sequencing question — what has to change before the entity exists. Ten business days, fixed fee, answered in writing.
Where a system change is already likely, a selection engagement takes it through requirements to a recorded recommendation, with global readiness as a first-class weighted criterion rather than a footnote.
We can have an NDA signed the day you ask.