Service United States Agent for Drugs Description U.S. Agent Services for API, Reagent and Cosmetics 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 your company and FDA in preparing for On Site Inspections Must have U.S. Agent Agreement and Drug Facility Registration included in your cart to register, Fee $725.00

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Service Drug Facility Registration Description 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. Fee $200.00 Quantity: Service Drug Registration and Listing Services Description 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. Fee $250.00 Quantity: Service Drug Master File Administrative Review Description DMF - Adminstrative Review of the Drug Master File prior to submission. Contact us for a quote. Extended Adminsistrative DMF Review service is a MUST, as mistakes in submission can cost excessive time and money. New DMF Review $125.00 per hour, Min 4 hours. Additional hours will be invoiced if required. Fee $500.00 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: