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January 28, 2022  •  Blog

The Right CMC Consultant Can Save You Time and Money

You are developing a new pharmaceutical product and think you would benefit from the services of a consultant with expertise in the Chemistry, Manufacturing, and Controls (CMC) requirements of global pharmaceutical regulatory bodies, but you also need to make the most of your CMC budget. Although CMC…

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June 25, 2020  •  Blog

CGMP Compliance Challenges with COVID-19 Infection

With the advent of Coronavirus (COVID-19) disease as a public health emergency, FDA has issued new guidance on COVID-19 infection in employees [Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing/ Guidance for Industry…

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