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