Manufacturer with limited eCTD knowledge and several Holder’s sites in the EU, US and China

  • Client needs to switch Master Files (MF) to eCTD format in EU, non-EU and US (later also APAC, CA)
  • Pressure from their clients (MAHs) to use eCTD
  • PharmaLex supported with:
    • Knowledge transfer, Project planning + management
    • Gap analysis and roadmap for transition
    • Full Regulatory Operations services during transition and on-going maintenance of eCTD-MFs (eCTD-readiness, compile, publish, submit)
    • Consultancy on CMC and (pre-)publishing topics and tools