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2022 ISPE Annual Meeting & Expo

SES103c - Building in Quality and Compliance from the Beginning

Oct 31, 2022 11:00am ‐ Oct 31, 2022 12:30pm


Phlow was founded in 2020 to establish reliable domestic supply chains for chronically out of stock essential medicines and to enable supply to underserved markets. COVID elevated the urgency and the company received a contract from the US government (BARDA) to support the mission for targeted APIs and finished doses.

Building a quality focus into the company culture while meeting the needs of an evolving start-up into a credible organization has been an essential part of the company’s growth. After the basic functions are addressed, implementing controlled workflows in advance of changing associated cGMP activities has been the primary driver. With no history to reference, the primary challenge is to implement while remaining agile to meet the expectations of multiple US government agencies, contractors, and customers, all in support of the company mission enabling improvements to supply chain reliability for the identified essential medicines and delivery to underserved patients.


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