A distillation of pharmaceutical knowledge and experience

 

 

Technology Platform

 

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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:

Transfer of products destined for the U.S. and Japanese markets
Tablets and capsules, including cytotoxic products
Sterile product to third parties including a third World contract manufacturer
Oral liquids/suspensions and topical preparations
Biologicals

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Process Mapping

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.

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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.

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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 facility for cytotoxic manufacturing and packaging
New dispensary for solid dosage forms and parenterals
Facility upgrade for tablet and sterile products manufacturing
Analytical testing laboratory upgrades

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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.

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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:

Validation of Computer Systems (e.g. SAP) including 21CFR Part 11
Process validations of major dosage forms
Manufacturing and laboratory equipment validation
Utilities validation
Analytical methods validation
Cleaning validation

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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:

Regulatory dossier compilation and review
Drug Master File update and review
Strategies for multi-market regulatory submissions

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Last modified: February 02, 2006
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