A
distillation of pharmaceutical knowledge and experience
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Technology/Product Transfer Process Mapping Root Cause Analysis/Risk Assessment New Facilities/Facilities Upgrade New Product Introduction Validation Regulatory Assistance and Support
Technology/Product
Transfer
QED-QED consultants have a proven successful track record of product transfers (and associated analytical methods) of varying dosage forms within companies and to third parties. Specific experiences include:
We have the capability and experience to assist you in the use of Process Mapping tools, including Lean Sigma techniques, to improve your manufacturing and packaging processes.
Root
Cause Analysis/Risk Assessment Root cause analysis and risk assessment is fundamental in determining product and process problems and issues. With over 45 years’ R&D and operational experience, QED-QED consultants can work with you to achieve high quality solutions in the shortest possible time using structured and proven techniques.
New Facilities and Facilities Upgrade With up-to-date regulatory, cGMP and validation knowledge and experience, QED-QED consultants have the expertise to work with you to ensure new facilities and facility upgrades are completed in optimal timeframe and in compliance with regulatory requirements. Typical examples include:
New
Product Introduction
QED-QED consultants have extensive R&D and commercial operations knowledge and experience in taking products from pre-clinical through to product launch. We can support you in all aspects of new product introduction such as, contractor selection, regulatory support, validation, training and inspection preparation.
Validation
The importance of successful validation cannot be under-estimated in assuring consistent and reliable products and processes. Our experience of hands-on involvement with validation projects ensures we have up-to-date knowledge of current industry issues and technologies. Our expertise include:
Regulatory Assistance and Support Regulatory approvals are the key to product survival. At QED-QED we have in-depth knowledge and expertise to assist you in gaining regulatory approvals for your products, new product introduction and line extensions. We can support you in the following:
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