CTD Module Writing and Review

  • Authoring CMC Module 3 sections for BLA / MAA and other regulatory submissions in Europe, USA and RoW markets (including redacted modules as needed)
  • Writing and reviewing all aspects of CMC Module 2 Quality Overall Summary (QoS) in CTD format (IND/IMPD) for CTAs related to small molecule and biotech products in EU, US and RoW
  • Drug Master File (DMF) reviews