UNITED STATES MANUFACTURERS AGENT FOR       DEVICES

U.S. Manufacturers Agent Basic Services:

• Responding to questions concerning the registrant's products that are imported or offered for import into the United States
• Assisting FDA in communications with the registrant
• Maintaining Secure Records as required by FDA regulations
• Assisting FDA in scheduling inspections of the registrant's foreign establishment
• Providing Hand delivery document submissions to the FDA/CBER offices for faster service.

New Registrants retain AGDE Corporation as your U.S. Manufacturers AGENT

• Click here to contact AGDE Corp and receive your U.S Manufacturers Agent Agreement and payment instructions

To Extend your current U.S. Agent Agreement Click on the Order Now button

Consulting Services

AGDE Corporations additional fee services for

Device Establishment Registration and Listing

• Review your completed Form FDA forms 2891/2892
• Assist in preparation with Registration and Listing:
• Review your Product Labels prior to submission
• Administrative Review of New 510(k)
• Review Pre-market Notification 510(k)
• Mock Inspections of your Facilities
• Quality System (QS) Compliance Review
• Small Business Qualification Certification Review

Click here to learn more and contact us for a quote