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, fax, and phone, we can get answers to your regulatory questions quickly and help you answer any questions that the FDA may have about your program. We routinely meet with FDA on behalf of our clients - approximately once every 3 weeks. We also help our clients prepare and conduct successful meetings with the agency.
Currently serving as US Agent for 25 small companies, but have provided US Agent services to over 60 companies, managing over 100 regulatory applications, over the course of the last 7 years.
Led or participated in 124 FDA Meetings – with experience in all types (A, B and C) of meetings.