Documentation and Quality Systems: Success is in the Details!

As a consultant, I work with a variety of pharmaceutical and biotech companies in many different stages of drug development. Some companies are trying to get their first drug into the clinic, while others are working on their first marketing approval. In the current industry environment, an increasing amount of work is outsourced as companies…
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The Drug Supply Chain Security Act: Current Impact

On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation under the FDA’s jurisdiction, one that eliminates the patchwork of state laws in…
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Regulatory Challenges of Orphan Drug Development

There are nearly 7,000 diseases that are considered rare in the United States. The majority of these diseases, which collectively affect 25 million Americans, are serious, life-altering, life-threatening, or fatal. A large number also have a genetic component or are the result of infectious agents. There have been several meaningful advances in rare disease product…
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