PharmaSafe - Full-spectrum cold-chain lodgistics consulting
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Home Page - Better Solutions For Getting Your Temperature-sensitive Products Safely To Market |
• PharmaSafe analyzes your existing processes to help customize more efficient, cost-effective ways to: • Package, Store, Distribute and Validate all of your temperature-sensitive pharmaceutical and biotech products |
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| About Ira Smith, PharmaSafe President |
• A leading consultant to the pharmaceutical and biotech industries • A specialist in the transport of temperature-sensitive products • Manages an ensemble of industry professionals who provide packaging, storage and distribution services for temperature-sensitive products • Selected by the United States Pharmacopoeia (USP) to serve as advisor on the subcommittee to restructure guidelines for packaging, storage and distribution of pharmaceutical products • Formed a team of specialists to develop a self-contained modular chamber and logistical procedure to ensure the efficacy of pharmaceutical products from the manufacturing plant to the customer’s door (patent pending) • Sat as an advisor on Merck’s Corporate Logistics Advisory Council • Helped Merck set up a major distribution center in the Netherlands |
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| PharmaSafe Helps You... Ensure FDA compliance and USP compliance | • We work with you to make sure that you: • Develop GMPs (Good Manufacturing Practices) • Avoid losses, fines and shutdowns [483], delayed product launches and clinical trials • Protect you and your consumers by delivering safe products |
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| Total Project Management | Do your departments share information? Does marketing know what’s going on in logistics, and does logistics know what packaging is planning? Sharing information among departments is the first step in making sure things run smoothly. Early on in any project, PharmaSafe comes on board to build communication and teamwork both within and among all of your departments.
Whether we help with just a piece or a whole project, you get a productive, reliable thoroughly integrated network of product support that can handle any project you take on: • Regulatory, information technology and staff training |
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| Increase Your Profit Margin | We show you more cost-effective ways to:
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| Jump Start Supply-chain Efficiency | We help make it easier for you to:
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| Contact | You can contact PharmaSafe using any of the methods listed below.
Mailing Address: PO Box 10900 New Brunswick, NJ 08906 |
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| Analyze Shipping Needs | • Analyze and evaluate total shipping process • Transportation cost reduction • Service improvement • Transit time reduction • Vendor management • Bid solicitation |
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| Audit Distribution Network | • Total mapping of distribution network • Step by step analyse of each area of the distribution process • Evaluate order to delivery process • Proposal for improved network effiency |
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| Consultation | • PharmaSafe will help you target in on immediate areas of concern • Provide needs assessment reports • System overviews • Map out solution processes |
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| Design Proposals | • Design secondary packaging • Design temperature controlled packaging • Work with existing packaging departments • Time temperature shipping profiles |
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| Document SOPS and GMPS | • Establish and/or revise Standard Operating Procedures (SOP) • Establish and/or revise Good Manufacturing Practices (GMP) • PharmaSafe will make sure all departments will be informed of SOPS and GMPS in document form • USP / FDA compliance issues are handled |
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| Supply chain logistics, evaluation and strategy | • Supply chain efficiency • Areas of improvement • Vision, objectives, strategies and tactics • Warehouse Management Systems • Transportation Management Systems • Inventory Management Systems • Order Management Systems |
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• Create greater warehouse efficiencies for storing and packing out temperature sensitive products |
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Whether we help with just a piece or a whole project, you get a productive, reliable thoroughly integrated network of product support that can handle any project you take on: • Regulatory, information technology and staff training |
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| Qualifications and testing |
• PharmaSafe has access to certified and approved testing facilities worldwide |
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| Temperature Controlled Packaging | • PharmaSafe will help you stay ahead of the technology curve by presenting the latest systems in the transport of temperature sensitive materials • Assist in the selection of validated temperature controlled packaging that includes: shippers, gels and time/temperature data loggers • PharmaSafe is an independent consulting company that is not affiliated with any manufacturer, resulting in the best possible solution for your needs |
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| Validate Storage Facilities | • Ensure FDA/USP facilities requirements for temperature controlled shipping • Establish documented SOP and GMPS |
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| PharmaSafe encourages strong partnerships with your vendors to ensure quality and economy |
• Manage and strengthen vendor relationships
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Copyright 2003 PharmaSafe LLC |
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