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Category: Regulatory Support

Analytical Testing for Drug Development
How do you ensure that your active pharmaceutical ingredients, their starting materials and intermediates,...
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How to Stay Compliant in a Changing Pharma Regulatory Landscape
In 2012, contaminated medications from the New England Compounding Center (NECC) caused a meningitis...
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Understanding 505(b)(2) Drug Development & API Supply Issues
Situated between the NDA and the ANDA is an increasingly popular drug commercialization pathway – the...
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