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Biopharmaceutical Manufacturing: The Challenge of Global Regulatory Compliance
- Article from:
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Pharmaceutical Technology
- Article date:
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June 1, 2008
- Author:
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Copyright informationCopyright Advanstar Communications, Inc. Jun 2008. Provided by ProQuest LLC. (Hide copyright information)
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This article provides an overview of key regulatory issues facing companies that seek to market their biopharmaceutical agents globally, including a trend toward harmonization of requirements as well as the remaining differences in rules concerning applications, good manufacturing practices standards, and communication with reviewers.
In recent years, biopharmaceutical companies have joined Big Pharma in expanding their businesses into global markets. In the process, many of these companies have found that navigating disparate regulatory requirements can be confusing, time consuming, and risky. A lack of understanding about a particular regulatory agency's requirements for processes or ...