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Regulatory Support Documentation for BioProcess products
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Regulatory Support Documentation for BioProcess products - 1

GE Healthcare Life Sciences Regulatory Support Documentation BioProcess™ products

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Regulatory Support Documentation A reliable companion from process development to market approval For products used in regulated environments, GE Healthcare Life Sciences offers a vast range of Regulatory Support Documentation to help you with: • Process development • Validation • Preparation of Standard Operating Procedures • Quality control • Support of your clinical and marketing applications to regulatory agencies The Regulatory Support web site On the Regulatory Support site, www.gelifesciences.com/rsf, you gain direct access to: • Regulatory Support Files • Validation Guides •...

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Regulatory Support Files WHAT Documentation for BioProcess chromatography media. Detailed information on performance, stability, extractable compounds, and analytical methods. Available by subscription from the Regulatory Support web site www.gelifesciences.com/rsf Validation Guide WHAT Documentation package available for different types of single-use products and process filters. Includes information on product characteristics, material and requirement specifications, manufacturing processes, qualification tests, and extractable compounds. Available by subscription from the Regulatory...

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For local office contact information, visit www.gelifesciences.com/contact www.gelifesciences.com/rsf GE Healthcare Bio-Sciences AB Björkgatan 30 751 84 Uppsala Sweden GE, imagination at work, and GE monogram are trademarks of General Electric Company. ÄKTA, BioProcess, ReadyCircuit, ReadyToProcess, UNICORN and WAVE Bioreactor are trademarks of GE Healthcare companies. © 2012–2013 General Electric Company – All rights reserved. First published Jan. 2012 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. A copy...

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