FDA Liaison Services
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FDA Liaison Services

Your Direct Connection to the FDA

Overview

Foreign establishments that manufacture, prepare, propagate, compound, or process drugs intended for import into the United States must designate a US Agent per 21 CFR § 207.69(b). As your designated US Agent, we serve as the official point of contact between your establishment and the FDA. We receive and respond to communications from the agency on your behalf, ensuring you remain compliant and informed about all FDA interactions affecting your business.

Key Features

Official US Agent designation in FDA systems
Receipt and forwarding of all FDA correspondence
Immediate notification of urgent FDA communications
Coordination of FDA inspection scheduling
Response facilitation for FDA information requests
Dedicated US-based regulatory contact

Our Process

1

Engagement & Setup

We gather your establishment information and complete the US Agent designation in FURLS.

2

Communication Protocol

We establish clear protocols for how FDA correspondence will be handled and forwarded to you.

3

Ongoing Monitoring

We monitor for all FDA communications and provide immediate notification for time-sensitive matters.

4

Response Coordination

When FDA requires a response, we help coordinate and ensure timely, accurate replies.

Project Complete & Deliverables Provided

Frequently Asked Questions

A US Agent is a person or company residing or maintaining a place of business in the United States that FDA can contact on behalf of a foreign establishment. The US Agent must be physically present in the US, available during business hours, and able to respond to questions about your establishment's drug products. It's a legal requirement for foreign drug establishments under 21 CFR Part 207.

Why Choose Us

  • Full compliance with FDA US Agent requirements
  • No missed FDA communications or deadlines
  • Expert handling of sensitive agency interactions
  • Reduced risk of import alerts or holds
  • Peace of mind with responsive US-based support

Get More Details

Request a personalized consultation and detailed information about this service.

Personalized consultation
Detailed service information
Custom timeline & proposal
Request Information

We'll respond within 24 hours

Ready to get started?

Contact our team to discuss your specific needs for FDA Liaison Services.

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What Our Clients Say

"When FDA issued an urgent communication about one of our products, Adelphi notified us immediately and helped us respond within the required timeframe. Their responsiveness prevented what could have been a serious import issue."

Hans Mueller

Director of Regulatory

European Pharmaceutical Manufacturer

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Establishment Registration

Complete support for FDA FURLS registration, annual renewals, and drug listing requirements.

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Communication Management

Receipt and prompt forwarding of all FDA correspondence, including inspection notifications.

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Inspection Support

Coordination of FDA inspection scheduling and logistics, ensuring preparation and responsiveness.

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