Regulatory & Quality: US Market Entry

1. We know the US regulatory pathway for each product and how long it takes.

2. Our US launch plan has an owner, a budget and dated milestones.

3. We have checked our claims and labeling against US rules.

4. We have decided who will be our US agent, importer and responsible person.

5. We have the US quality and regulatory leadership we need, or a plan to get it.

6. Decision rights between headquarters and the US team are written down.

7. We have decided whether to manufacture, warehouse or distribute in the US.

8. Any US site meets registration, listing and inspection requirements.

9. Our supply chain into the US accounts for customs, tariffs and lead times.

10. Our quality system has been gap-assessed against US requirements.

11. Records and documents are controlled and would satisfy a US inspector.

12. Complaint handling and adverse event reporting work for US customers.

13. We have a realistic budget for US entry, including fees, people and remediation.

14. We know the go and no-go points for US launch.

15. Our board agrees on the timeline and the money behind it.