US Agent

Asla Partners provides a U.S.-resident agent to serve as the contact between FDA and your foreign drug or cosmetic manufacturing facility.

 Request US Agent Service

What is a US Agent?

A US FDA Agent is a person or company physically located in the United States that serves as the official point of contact between your foreign establishment and the FDA. The FDA sends all regulatory communications, including inspection notices, warning letters, compliance inquiries, and safety alerts, to your US Agent, not directly to your facility. Receipt by your US Agent is legally equivalent to receipt by your company.

Your US Agent must have a real US street address (not a PO box or answering service), be available to receive FDA communications during regular US business hours, and be prepared to respond to urgent notifications at any time.

Who needs a US Agent?

A US Agent is mandatory for any foreign establishment registering with the FDA. This includes:

  • Foreign drug manufacturers (OTC, prescription, generic, API) under 21 CFR Part 207.
  • Foreign cosmetic facility operators registering under MoCRA FD&C Act Section 607.
  • Foreign applicants of IND, NDA, ANDA, NADA, and ANADA submissions
  • Companies submitting controlled correspondence to the FDA

Why choose Alsa Partners?

What Asla Partners do as a US Agent

  • Accepts and manages all official FDA communications on your behalf
  • Assists the FDA in scheduling inspections of your foreign establishment
  • Assists with drug establishment registration and drug product listing (NDC number)*
  • Assists with MoCRA cosmetic facility registration and cosmetic product listing*
  • Monitors and manages annual or biennial renewal deadlines for your registrations
  • Responds promptly to FDA inquiries - always available during US business hours

* These support may provided to clients who have separately engaged for those services.

 Appoint us as your US Agent

US Agent Fees

US Agent Service

per facility

$199/yr

FAQ

Can Asla Partners serve as our U.S. Agent?

Yes, Asla Partners can serve as the U.S. Agent for foreign facilities that require a U.S. Agent for FDA registration. We are physically located in the United States and will respond to FDA on your behalf.
Can Asla Partners respond to FDA on our behalf?

As you designate us as US Agent, we receive and manages all official FDA communications on your behalf.
Will the annual fee remain $199 from the second year onward?

We provide our existing clients with long-term price protection. As long as your U.S. Agent service remains continuously active with us, your annual renewal fee will stay fixed at $199 per facility, regardless of any future increases to our standard service pricing.
Can we change our U.S. Agent later?

Definitely. You may change your U.S. Agent at any time if you launch an eligible U.S. entity or decide to work with another service provider.

The applicable FDA registration must be updated, and the newly designated U.S. Agent may need to confirm the appointment. Any transition should be coordinated carefully to avoid a gap in FDA communications.