US Agent

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As a US Agent, we communicate directly with the US FDA on behalf of a sponsor. For companies that do not have a US presence, a US Agent is required to bring investigational or marketed product into the US. For companies that have a US presence, a contract US agent is desirable when regulatory expertise is not available in house or resources are limited.

The role of US Agent is critical to a company’s ongoing regulatory success. A good US Agent is one who understands your science and has a deep history of working directly with FDA. We foster collaborative, dynamic relationships with FDA (CDER, CBER, and CDRH) on your behalf to progress your product(s) through development. Using secure email, phone, and fax, we can get answers to your regulatory questions quickly and help you answer any questions that the FDA may have about your program. We interact with the FDA on a daily basis on behalf of our clients. We also help our clients prepare and conduct successful meetings with the agency.

AWARDS & RECOGNITION

great place to work certified badge for may 2023 to may 2024 USAtop regulatory services provider 2023 award awarded to facet life sciences by life sciences review.great place to work certified badge for april 2024 to april 2025 USAtop regulatory services provider 2024 award awarded to facet life sciences by life sciences reviewtop regulatory services provider 2025 award awarded to facet life sciences by life sciences review