Chemistry, Manufacturing & Controls

  • CMC (Quality) Data Review and Gap Analysis
  • Process control & characterization
  • Analytical and bioanalytical methods validation
  • Extractables and Leachables
  • Photostability studies
  • Technology transfers
  • Comparability studies
  • Investigational Medicinal Product Dossier (IMPD) quality documentation writing
  • New Drug Application (NDA) writing of Module 2 & 3
  • Clinical trial supply logistics
  • Serialization setup
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