U.S. FDA U.S. Agent Registration
WFC helps foreign clients to find US agents to liaise and communicate with the FDA on behalf of clients. Our partners handle all FDA communications on important regulatory information (compliance issues, product-related issues, inspection schedules and others) leveraging industry know-how, a team of experts with long tenure in FDA approval processes, and a clear understanding of all regulatory compliance matters to avoid costly and time-consuming errors.
How our partners help our clients:
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- Assist FDA in communication with the foreign manufacturer
- Assist FDA in scheduling inspections of the foreign manufacturer
- Annual update of registration and listing records
- Initial listing of products that will be imported
- Initial registration of the new establishment
- Importation letter template to facilitate importation
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