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2016-08-02 Pharmaceuticals - BFS products:

Your chances of passing an FDA (or EMA or other highly regulated country) inspection with the data you have is very close to zero. Sorry.     As I have made BFS PE containers and have been able to attain

2016-08-01 Pharmaceuticals - BFS products:

Dear Misa:    As you have to demonstrate a minimum of Fo = 8, I am not sure that you will have success in registering the product. with an Fo of <3. For this study you need to use pharmacopoeial recognized

2016-07-11 Biotech & Biomedical - Important major:

Hi, Hiam,    Thanks for your question.    The old empirical way of finding new drugs or lead compounds for developing new drugs is long gone - we used to search 1000's of compounds and look at their properties

2016-07-06 Pharmaceuticals - GMP certification:

Jose:    When FDA inspects an overseas company they can either issue a decision of "No Action Indicated" (NAI) meaning that the company has no or minor issues that will be fixed and that FDA is basically

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