If you’re a medical device company based outside the US, appointing a US Agent is more than just an FDA requirement — it’s a critical part of your regulatory success.
But not all agents are created equal.
We provide US Agent services backed by regulatory expertise, so you’re not just meeting the requirement but also working with someone who understands what’s at stake.
What we do:
- Represent you as your official FDA point of contact
- Respond to FDA inquiries on your behalf
- Guide your team through 510(k) submissions and compliance needs
- Help you avoid costly delays and misunderstandings
What sets us apart
- We’re part of NSF, a global organisation with deep regulatory expertise
- Our team includes former FDA regulators and industry professionals
We’ve supported medical device companies worldwide with FDA submissions, inspections, and US market entry. And we’re here to support you, too — with experience far beyond paperwork.
