U.S. FDA Food Facility services $150.00 per year per facility.
Extended
Assist with U.S. FDA Food facilities registration
Serve as your Regulatory Liaison in communicating with FDA Officials on behalf of you our client, regarding its product(s) for export to the U.S. Market
Provide up to date information to you regarding Compliance.
AGDE Corporation offers 24 hour / 7 day a week customer service.
Assist FDA and our clients coordinate Site Inspections.
Must have U.S. FDA Food Agent Agreement included in your cart to register.
U.S. FDA Drug Facility services $200.00 per year per facility.
Extended
Must Have U.S. Agent FDA Drug Agreement
Serve as your Regulatory Liaison in communicating with FDA Officials on behalf of you our client, regarding its product(s) for export to the U.S. Market
Provide up to date information to you regarding Compliance.
AGDE Corporation offers 24 hour / 7 day a week customer service.
Assist FDA and our clients coordinate Site Inspections.
U.S. FDA Device Facility services $200.00 per year per facility.
Extended
Assist FDA in Communicating with Device Facilities Operators Must Have U.S. FDA Device Agent Agreement
Serve as your Regulatory Liaison in communicating with FDA Officials on behalf of you our client, regarding its product(s) for export to the U.S. Market
Provide up to date information to you regarding Compliance.
AGDE Corporation offers 24 hour / 7 day a week customer service.
Assist FDA and our clients coordinate Site Inspections.
Biologics Facility services $200.00 per year per facility.
Extended
Must Have U.S. Agent for Biologics Agreement
Serve as your Regulatory Liaison in communicating with FDA Officials on behalf of you our client, regarding its product(s) for export to the U.S. Market
Provide up to date information to you regarding Compliance.
AGDE Corporation offers 24 hour / 7 day a week customer service.
Assist FDA and our clients coordinate Site Inspections.
Review and submisson of U.S. FDA Forms 2656 and 2657 for Drug Registration and Listing Forms
Extended
Fee $125 per hour Minimum 2 hour review Assist in preparation of Registration and Listing Review your completed Form FDA-2656, 2657 Review your Product Labels prior to submission Package FDA forms and labels for FDA hand delivered submission.
Review and submisson of U.S. FDA Biologics or HCT/P Registration and Listing Forms
Extended
Fee $125 per hour Minimum 2 hour review Assist in preparation with Registration and Listing of: Blood Establishment Registration (Form FDA 2830) Tissue Establishment Registration (Form FDA 3356) Biological Product Deviation Reporting (Form FDA 3486) Review your completed FDA-2830, 3357or 3486 Forms Review your Product Labels prior to submission Package FDA forms and labels for FDA hand delivered submission.
