Foreign sponsors of drug applications who want to conduct business in the United States need an authorized U.S. Agent to interact with the FDA on their behalf. Expectations for the individual or company serving as the U.S. Agent should go beyond forwarding email and monitoring the fax machine. The U.S. Agent should add value in the form of regulatory insight and operational efficiency as you navigate the FDA apparatus. Besides, BLA Regulatory provides representation as both, U.S. Agent and for eCTD submission services. Our responsibilities include:
- Review, dissemination, routing, and response to all communications from FDA
- Reliable experts in an evolving regulatory landscape to help foreign sponsors remain compliant
- Response to questions concerning those drugs that are imported or offered for import to the United States
- Assisting the FDA in scheduling inspections