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

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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 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: