Market-entry route
Turn an ambiguous U.S. expansion goal into a staged plan with owners, evidence, dependencies, and go / conditional-go / no-go gates.
Coordinated services
The right work, in the right order, with the right owner.
CFO scopes the route and coordinates execution. Regulated, licensed, and approval-bearing work stays with qualified providers and decision-makers.
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Not every project needs every workstream. Qualification determines the route.
CFO bilingual flagship offer
U.S. Market Entry & Amazon Launch
CFO leads the bilingual client journey, USAVIP underpins company/EIN/address/banking support, and Amazon seller-account and FDA U.S.-agent coordination remain separate modules.
Explore the complete offer →Company, EIN & banking coordination
Coordinate U.S. company formation, genuine ownership and responsible-party information, the EIN route, address and tax work, then bank-account application support through appropriate providers. Neither an EIN nor a bank account is guaranteed.
FDA U.S.-agent sourcing
Help identify and coordinate a qualified U.S.-based provider for the foreign manufacturer’s limited FDA liaison role. The U.S. agent is not automatically the initial importer and does not own MDR reporting or 510(k) submission duties.
Importer & operating-route design
Separately identify the initial importer, staffed U.S. presence, title flow, customs route, 3PL, complaint/MDR owner, and correction/removal responsibilities with qualified providers.
Amazon seller readiness
Prepare the company and evidence route for a new or existing Amazon seller-account application, brand and product review, logistics, and restricted-product requirements. Amazon makes every approval decision.
Transaction coordination
For suitable cross-border acquisitions or asset transitions, coordinate diligence, documents, escrow, providers, milestones, and handoff evidence.
Post-launch operating support
Create a defined support cadence for open issues, provider coordination, renewals, and evidence maintenance.
Four separate roles
One “U.S. contact” is not the operating route.
The company, FDA U.S. agent, initial importer, and Amazon seller carry different responsibilities. Qualification identifies which roles exist, which must be sourced, and who is accountable for each.
The client’s U.S. company
Owns the business, EIN, bank application, and Amazon seller account. It should use the client’s genuine ownership and responsible-party information, with tax and legal routes confirmed by qualified providers.
FDA U.S. agent
Serves as the foreign manufacturer’s limited U.S. liaison with FDA. This role does not automatically include initial-importer, MDR-reporting, or 510(k)-submission duties.
Initial importer & U.S. operator
A separate role that may carry registration, MDR, corrections/removals, tracking, complaint-forwarding, and staffed U.S.-presence duties. A qualified regulatory provider must confirm the exact route.
Amazon seller
Applies with an eligible entity, beneficial-owner, banking, and product evidence package. CFO can coordinate preparation; Amazon alone decides whether to approve the account or product.
Commercial model
Scope first. Fees second.
Service fees follow the project stage, work scope, and responsibility boundary. The website does not publish generic prices or promise third-party costs or approval outcomes.
Initial qualification
We first review high-level facts to decide whether a paid assessment is appropriate. Qualification is not a feasibility, approval, or final-pricing promise.
Fixed-fee route memo
A defined, fixed-fee engagement maps the company, EIN, banking, FDA, import, and Amazon routes, missing evidence, providers, budget ranges, and decision gates.
Milestone coordination fees
Implementation is quoted under separate work scopes and milestones. Each stage begins only after its written scope, owner, deliverables, and payment gate are accepted.
Third-party costs separated
Legal, tax, registered-agent, FDA U.S.-agent, initial-importer, customs, 3PL, banking, and other professional-provider charges are itemized separately and preferably paid directly by the client.
Clear roles reduce risk
Coordination without overreach.
- CFO is a commercial coordinator, not a law firm, CPA firm, bank, broker-dealer, FDA agent, customs broker, or Amazon affiliate.
- FDA establishment registration and device listing do not mean that FDA has certified, cleared, or approved a manufacturer or device.
- Regulatory, legal, tax, customs, banking, and other licensed opinions come from separately engaged qualified providers.
- No FDA clearance, import acceptance, bank account, marketplace approval, financing, investment return, or transaction closing is guaranteed.
- Third-party eligibility, timing, fees, and decisions remain outside CFO’s control.