Service United States Agent for Biologics Description U.S. Agent Services for Biologics and HCT/P Manufacturers Extended United States Agent Services  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 FDA in preperations for On Site Inspections Must have U.S. Agent Agreement and Biologics Facility Registration included in your cart to register, Fee $725.00

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Service Biologics Facility Registration Description 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. Fee $200.00 Quantity: Service Biologics Registration and Listing Services Description 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. Fee $250.00 Quantity: Service Quality Systems/CGMP Review Description Full CGMP or HACCP Review - Call for quotaion Extended Services include full mock inspection by a certifed consultant. The API chemistry, manufacturing, and controls audit includes:   * Quality Management   * Personnel   * Buildings and Facilities   * Process Equipment   * Documentation and Records   * Materials Management   * Production and In-Process Controls   * Packaging and Identification Labeling     of APIs and Intermediates   * Storage and Distribution   * Laboratory Controls   * Validation   * Change Control   * Rejection and Reuse of Materials   * Records and Reports   * Recalls   * Contract Manufacturers (Including     Laboratories)   * Agents, Brokers, Traders, Distributors,     Re-Packagers and Re-Labelers      Fee $0.00 Quantity: