Services

U.S. regulatory support built around the actual agency workflow.

Different agencies use different legal authorities, filing systems and agent concepts. We scope each engagement around the rule that actually applies.

How the workflow works

  1. 01

    Confirm the exact regulatory pathway and the role the U.S. contact must perform.

  2. 02

    Collect the manufacturer, product, filing and existing representative information.

  3. 03

    Prepare or coordinate the designation, filing or data handoff and keep the record current.

Keep the technical work with the technical team.

We are not a testing laboratory or certification body. We work alongside laboratories, TCBs, brokers, importers and compliance advisers.

U.S. REGULATORY HUB

Need the U.S. side of the workflow to be owned?

Send the agency, product, manufacturer country and current filing status. We will identify the U.S. support path that fits.

Discuss your U.S. setup