- Registration starting material strategy
- Impurity management – fate and linkage
- Potential genotoxic impurity management
- API manufacturing and analytical information in formats appropriate for inclusion in regulatory filings (CTD Section 3.2.S.1 through 3.2.S.7)
- Drug product manufacturing and analytical information in formats appropriate for inclusion in regulatory filings (CTD Sections 3.2.P.1 through 3.2.P.8)
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