(FDA AGENT - US REGISTERED)
The United States Food and Drug Administration (FDA) requires all medical device, IVD, pharmaceutical, cosmetic and food companies with no locations in the United States to appoint a registered FDA Agent. An appointed FDA Agent must be a resident of the United States or maintain a place of business in the US.
As your agent:
- We act as a liaison between your company and the FDA, responding to questions concerning your products, assisting FDA in scheduling inspections and helping you resolve problems or delays.
- We ensure that all regulatory responsibilities and interests of our clients are handled professionally, confidentially and promptly.
- We are an independent “third party” that will always look after your interests. Manufacturers who appoint a distributor to act as their FDA Agent may experience problems in this regard.
- Affordable annual fee for US Agent representation.
International callers: 1-919-942-1634
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FDA Compliance Help Desk™
1289 N. Fordham Blvd. Suite A-128
Chapel Hill, NC 27517 USA
Phone 919.942.1634
Copyright © 2004 - 2005 FDA Compliance Help Desk, Inc.
Last modified: April 16, 2007
FDA Compliance Help Desk, Inc. is a for profit NC corporation and is not affiliated with the U.S. Department of Health and Human Services.