CMC CTD Support

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  • 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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1F & 3F, Block A
2829 JinKe Road
Zhangjiang Hi-Tech Park
PuDong New Area
Shanghai China, 201203

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Europe: +45 4586 9000

contact@chempartner.com