UNITED STATES AGENT FOR:

• HCT/Ps
• Blood Products
• Tissue Products
• Biological Products

 U.S. Agent for Biologics 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 AGENT for Biologics

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

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

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 AGDE Corporation Consulting Services

 AGDE Corporations additional fee services for

 Biologics Establishment Registration and Listing

• Establishment Registration (Form FDA 3356)
• Establishment Registration (Form FDA 2830)
• Deviation Reporting (Form FDA 3486)
• Assist with Licensing and Registration
• Review of completed Form FDA-2830/3356/3486
• Review of Product Labels prior to submission
• Administrative Review of New 510(k)
• Review Pre-market Notification 510(k)
• Mock Inspections of your Facilities
• Complete CGMP Review
• Small Business Qualification Certification Review

   Click here to learn more and contact us for a quote