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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 EMA

July 8, 2022

Orphan Drug Designations in the U.S. and EU

What is an Orphan Drug Designation? The Orphan Drug Designation (ODD) program in both the United States (U.S.) and European Union (E.U.) qualifies sponsors to receive potential incentives to develop...

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FDA Agency Alerts

July 25, 2016

FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications

FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...

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