US Agent Services

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FDA US AGENT CASE STUDY


CHALLENGE:
A startup company in France successfully completed their US market clearance for an imaging device and selected a US distributor. After registering their manufacturing establishment in France with the FDA, the company became aware of the FDA’s requirement to appoint a US Agent. Their distributor was unwilling to take on this role.


APPROACH:

AlvaMed explained the role of the US Agent to the startup’s founders. The company was comfortable handling all postmarket reporting requirements directly with the FDA, so AlvaMed offered to serve as the US Agent for a nominal yearly fee and provide expert assistance on an “as needed” basis.


RESULTS:

AlvaMed provided a cost-effective approach to meeting the client’s regulatory requirements for US Agent service. As the company grew, they opened their own US subsidiary to serve as their in-house sales and distribution office. AlvaMed smoothly transitioned US Agent responsibilities to the US subsidiary once the client was ready. 

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