U.S. FDA and CDER SERVICES

Information:


  • 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.

MEDEXMOBILE +

Medical Trailers/Vans and Supplies

COMPUTERS

Computers Hardware and Software Sales

IT Technical

Consulting Services

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 ?