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Regulatory Affairs Quality Team

Margrethe Erbou Andersen is heading a group of regulatory affairs specialists with expertise in Quality (CMC) regulatory affairs.

The RA Quality team:Regulatory Affairs Quality, eCTD & QA

  • provides consultancy on CMC development strategies through all phases of development, and on CMC lifecycle strategies in the post-approval phase
  • handles all types of CMC documents (writing, reviewing, updating etc.):
    • Module 2.3, and Module 3 documentation
    • IND’s and IMPDs
    • ASMF’s/DMF’s for drug substances
  • manages CMC variations in the EU and amendments/supplements in the US
  • prepares applications for registration of Certificates of Suitability (CEP) with EDQM

We collaborate closely with the other IWAC teams on submission strategies and submission handling, and prepare all documentation in current eCTD format for submissions world-wide.

For more information about our team and expert services, please contact Margrethe Erbou Andersen.