EuropeanRegulatory Gate
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Commercial Terms

Last updated: 2026-09-23

Packages

  • Gate Snapshot — free. Five headline numbers and one critical flag, no detailed explanation. Drafted with AI assistance and released by an AFINA expert, usually within 1–2 working days of your submitted intake.
  • Gate Decision — €490. Regulatory classification, applicable requirements, full Regulatory Entry Budget, time-to-market timeline, regulatory risks, expert review call.
  • Gate Strategy — €990–1,490. Everything in Gate Decision, plus alternative regulatory design scenarios and potential savings where supported by the budget analysis.

The package and final price for your case are confirmed in a quote after our eligibility review — before you pay. Some product categories (for example borderline medical devices, chemical mixtures, children's products, high-risk devices) need a separate evaluation before a standard timeline can be committed.

VAT

Regulatory Gate is sold to businesses. The seller, AFINA, spol.s r.o., is VAT-registered in the Czech Republic (VAT number CZ25056557). All prices are shown excluding VAT.

Business customers in other EU member states who provide a valid VAT number are invoiced without VAT: the reverse-charge mechanism applies and the customer accounts for the VAT. Customers established in the Czech Republic are invoiced with Czech VAT. If you do not provide a valid VAT number, we review the order and confirm the VAT treatment on your quote before you pay.

Delivery time

The Gate Report is delivered within 5 business days of payment and complete input. Time during which we are waiting for information, documents or answers from you does not count towards the 5 business days. When we are waiting for you, we mark this in your case and show what we need; the period ends when you respond.

Revisions

A report is issued against a frozen scope; changes to the product, intended purpose or claims after that point are handled as a change request. Your price includes one clarification round after delivery (questions about, or corrections of factual errors in, the report). Any further change, or a change to the scope, is quoted separately and only starts once you accept the quote.

Payment

Payment is made online through our payment provider (Stripe) before the assessment starts. Card details are entered with the provider and are not stored by us.

Refunds and cancellation

The price is confirmed in your quote before you pay, and the assessment starts once payment is received. Payments are final and non-refundable. This does not affect any rights that cannot be excluded by law.

Regulatory Gate is offered to businesses only, so the statutory withdrawal rights that apply to consumers do not apply.

Invoices

Invoices are issued by AFINA, spol.s r.o., Kaprova 42/14, 110 00 Praha, company number 25056557, after payment is received. Payment is due at checkout, before the assessment starts, so no payment period runs after delivery. Prices and invoices are in euro (EUR).