FDA U.S. Agent Services for Regulatory Compliance

U.S. Agent ServicesEnsure FDA compliance with a U.S. agent

LexisNexis Life Science is your FDA point of contact and supports registration, communications, and inspection scheduling.

LexisNexis Life Sciences Solutions cosmetic services navigate SPL requirements by managing structured product labeling submissions end to end, ensuring compliance with MoCRA requirements. Leveraging a proven XML data standard used across regulatory programs, we deliver accurate, consistent, and submission-ready data.

RegistrationMeet FDA U.S. agent requirements

Companies selling or distributing pharmaceutical products in the U.S. market are required by law to identify a U.S. Agent. LexisNexis Life Science can serve as your U.S. Agent to help ensure compliance with applicable FDA regulations.

CommunicationCentralize FDA correspondence management

Centralize communication management for all FDA correspondence, including emergency communications. Coordinate communication pathways and ensure timely responses to FDA inquiries for compliance.

OperationsSupport inspections and import inquiries

Address inquiries concerning drugs imported or proposed for import into the United States. Collaborate with the FDA to facilitate inspection scheduling, contributing to regulatory compliance and operational continuity.

LexisNexis Life Sciences support

These are the key services LexisNexis Life Sciences provides as your U.S. Agent to help you manage FDA establishment registration and stay on top of FDA communications.

FDA point of contact

Serve as the FDA point of contact for foreign drug, biologic, and device companies based outside of the U.S. Designate an official contact for each establishment as a U.S.-based extension of your team.

Registration and listing support

Assist with registration and listing information to meet FDA requirements. Support review and preparation of regulatory submissions as part of U.S. Agent responsibilities.

FDA correspondence management

Centralize communication management for all FDA correspondence, including emergency communications. Coordinate communication pathways and support timely responses to FDA inquiries.

Ad hoc compliance consulting

Provide ad hoc regulatory compliance consulting on FDA correspondence or inquiries related to establishment registration.

Import inquiry support

Address inquiries concerning drugs imported or proposed for import into the United States.

Inspection scheduling support

Collaborate with the FDA to facilitate inspection scheduling. Assist with FDA inspections as part of U.S. Agent responsibilities.

Data Security, Privacy, and Governance

Security and privacy you can count on

Privacy by design

LexisNexis protects customer data wherever it is stored, sent, or accessed. We apply privacy by design principles at every stage of development to ensure security and compliance are built in from the start. Our advanced encryption and rigorous compliance protect your sensitive information. 

Strict security protocols

LexisNexis systems meet the highest standards for information security. We partner with trusted, enterprise-grade cloud providers, continuously monitor and improve our infrastructure,
Explore the LexisNexis Trust Center

Who are U.S. Agent Services for?

U.S. Agent Services are for foreign drug, biologic, and device companies based outside of the U.S. that sell or distribute pharmaceutical products in the U.S. market and must identify a U.S. Agent. LexisNexis Life Sciences supports foreign establishments with a U.S.-based FDA point of contact for establishment registration and FDA communications. Don’t see who you’re looking for? Contact us for a customized demo.

  • Foreign drug companies
  • Biologic companies
  • Device companies
  • Foreign establishments
  • Regulatory teams
Frequently asked questions

What are US Agent Services?
US Agent Services are designed to support compliant establishment registration and effective regulatory communication with the FDA, in line with Sec. 207.69. LexisNexis Life Sciences serves as the FDA point of contact on behalf of foreign establishments.

Companies selling or distributing pharmaceutical products in the U.S. market are required by law to identify a U.S. Agent. The U.S. Agent communicates with the FDA on behalf of the foreign establishment.

A U.S. Agent may review and prepare regulatory submissions, communicate with the FDA, respond to FDA inquiries, and assist with FDA inspections.

LexisNexis Life Sciences centralizes communication management for FDA correspondence, including emergency communications, and helps coordinate timely responses to FDA inquiries.

Yes, LexisNexis Life Sciences collaborates with the FDA to facilitate inspection scheduling and can address inquiries concerning drugs imported or proposed for import into the United States.

LexisNexis Life Sciences provides ad hoc regulatory compliance consulting to advise on FDA correspondence or inquiries related to establishment registration. Examples include assessing compliance risks, vulnerabilities, and FDA inquiry responses.

Talk to a Life Sciences Regulatory Professional Today

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Reed Tech is now LexisNexis Life Sciences Solutions

While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis.