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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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Quality & Compliance EudraLex Volume 4

April 24, 2023

Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023

The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...

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Life Science Consulting EudraLex Volume 4

October 8, 2020

EudraLex Volume 4, Annex 1 Update: What You Need to Know

EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...

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