US Agent Services aim to ensure compliant establishment registration and effective regulatory communication, in line with the specifications of Sec. 207.69 of FDA regulations. The services are designed to assist companies in meeting FDA requirements and facilitate clear communication between regulatory authorities and your establishment, contributing to regulatory compliance and operational continuity.

Reed Tech Support

• Designate an official contact for each establishment
• Assist with registration and listing information to meet FDA requirements
• Centralize communication management for all FDA correspondence, including emergency communications
• Coordinate communication pathways and ensure timely responses to FDA inquiries for compliance
• Address inquiries concerning drugs imported or proposed for import into the United States
• Collaborate with the FDA to facilitate inspection scheduling and regulatory compliance

Regulatory Compliance Ad Hoc Consulting:

As part of our U.S. Agent Services for FDA establishment registration, we provide ad-hoc regulatory compliance consulting to advise on any FDA correspondence or inquiries related to the establishment registration. Examples include assessing compliance risks, vulnerabilities and FDA inquiry responses.

Contact us at pharma@reedtech.com if you have questions about US Agent Services for FDA.

Every day, regulatory teams rely on the experienced guidance of Reed Tech for managing many stages of the drug lifecycle with data submissions to U.S. FDA and other Global Health Authorities. For non-U.S. based companies, we can serve as an FDA required, U.S.-based extension of your team, acting on your behalf for regulatory establishment registrations, freeing up your resources for other priorities.