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Kelly Dolezal, MS
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Batch Analysis Section of IMPD
Posted By
Kelly Dolezal
23-Sep-2016 17:40
Found In
Egroup:
RAPS Twin Cities Chapter
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I am stepping into a regulatory function, and have started by helping prepare the CMC section of submissions for a small molecule investigational drug product. Does anyone have experience with the CMC section of an IMPD? I am specifically trying to figure out the following: 1. I do not see a requirement ...
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