- FDA Food and Facility Registration.
- Device Establishment and Listings.
- Drug Master File (DMF) Review and Submissions.
- cGMP Audits - Facility and Process Assessment.
- 510(k) Review and Submission.
- Submissions Hand Delivered to FDA
- API Manufacturers that do not currently have a US agent are encouraged to contact AGDE Corporation for guidance.
What we offer: REGISTER NOW
- Maintenance of a U.S. place of business that meets FDA requirements.
- Complete Food, Drug, Biological and Medical Device registration of your company with the FDA as required by law.
- AGDE Corporation offers your company an expert team of import/export industry, government regulation and computer technology professionals.
- We have developed an advanced technical infrastructure to ensure confidential and expedient communications and registration processing.
- Registration updates as they are released by the FDA
As the Link between the U.S. FDA and your firm we will provide:
- Forwarding Information and documents received from the FDA to you, our client.
- Receiving FDA information and documents on behalf of the client should the FDA be unable to contact you in a timely manner.
- Assist the FDA in communicating with you, our client regarding its product for sale in the U.S.
- Provide a secure internet web site that allows clients to access FDA information relevant to your company and products
- AGDE Corporation offers 24 hour / 7 day a week customer service.
Medical Trailers/Vans and Supplies
Computers Hardware and Software Sales
You MUST register with the FDA to Import any food into the United States of America.
WHAT IF I DONíT GET AROUND TO REGISTERING?
DOES REGISTERING TAKE A LOT OF TIME OR EFFORT ?
WHAT IF I PICK THE WRONG AGENT ?
WHAT FACILITIES ARE NOT COVERED ?