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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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FDA NDA

May 18, 2022

FDA Releases Draft Guidance for Industry on Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies

The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences released a new draft guidance document that, for the first time, clearly addresses the FDA’s recommendations and...

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