Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

CDMO manufacturing biologic material for clinical trial Phase 1 and 2

  • 1.  CDMO manufacturing biologic material for clinical trial Phase 1 and 2

    Posted 28-Sep-2023 15:42
    Can anyone please comment on Drug substance and intermediate drug product manufacturing by a CDMO-what are the requirements for 1) sample retention and 2) Records retention for the CDMO as the supplier of the clinical material?





Related Content