UNITED STATES AGENT SERVICES FOR DRUGS

U.S. Drug Agent Basic Services include:

• 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. FDA DRUG AGENT

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

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

AGDE Corporation Consulting Services

AGDE Corporations additional fee services for

DRUG REGISTRATION AND ESTABLISHMENT LISTING

• Review completed U.S. FDA Forms 2656 and 2657
• Review annual 2656/2657 updates and amendments
• Review Product Labels text and graphics prior to submission
• Review product label graphics prior to submission
• Administrative DMF Review and submission
• DMF Amendments review and submission
• DMF Annual Update/Report Review and submission