Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: CMCeCTDDocumentSP4151 - Examples

Page standards status: Trial-use Maturity Level: 2

Examples for the cmc-ectd-document-sp4151 Profile.

3.2.P.4 Bundle
3.2.P.5.1 Bundle
3.2.S.4.1 Bundle