Service United States Agent Services for Medical Devices Description U.S. Agent Services to Medical Device Manufacturers Extended United States Agent Services  Assist Medical Device Establisment Registration and Listing forms 2891/2892 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. Must have U.S. Agent Agreement and Medical Device Facility Registration included in your cart to register,   Fee $725.00

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Service Medical Device Facility Registration Description 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. Fee $200.00 Quantity: Service Express Hand Delivery Description Promptly Hand Carry your documents to FDA/CDER/CBER and obtain receipt of delivery Extended Package FDA forms documents and labels for FDA hand delivered submission. Fee $75.00 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: