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ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

What are Quality Management Systems (QMS)?

March 4, 2024

What is Quality Management? Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all organizational processes are conducted in a documented, consistent, and controlled manner. An electronic...

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Compliance FDA

April 22, 2023

The Importance of Responding to FDA 483 Observations

This article has been updated since its original publication date. The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483...

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FDA Life Science Consulting

April 21, 2023

FDA Form 483: Common Pitfalls You Can Avoid

This article has been updated since its original publication date. FDA Form 483 requires a written response in which you must make it clear that you are taking the observations, and your...

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Quality & Compliance FDA

April 4, 2023

15 Days of Panic: You Received FDA Form 483 Warning Letter, Now What?

This article has been updated since its original publication date. Remember the last time you were pulled over by the police? Maybe you had a taillight out. Perhaps you were speeding. You may have...

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