TRANSFORMING CMC GENERATION THROUGH AUTOMATION AND STRUCTURED CONTENT
Challenge:
Automate the creation of CMC dossiers; collaborate more efficiently; omit tedious manual and error-prone data transcription; consolidate data from multiple sources; streamline the process to meet high regulatory standards for faster time-to-patient
Solution:
BIOVIA Structured Document Manager and the 3DEXPERIENCE® platform
Results:
- Cost savings of $2M/dossier
- 80% time reduction for stability, batch analyses and specifications sections
- 50% time reduction in CMC content authoring
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