Fig. 5

Comparison of regulatory submission processes with and without SCDM. A comparison of regulatory CMC submission assembly and dispatch is shown. Without SCDM, data is manually transcribed from the source into a technical report. The technical report is then used as a source document for a regulatory document, of which there are multiple regional variants created manually. Compilations of documents are then sent individually to health authorities for review, requiring the company to maintain multiple regional dossier variants. With SCDM, manual authoring steps can be reduced or eliminated as content and data can be taken directly from the source system, processed and semantically mapped via an enterprise data lake, and made available for incorporation in a regulatory filing via the structured content and data library, which is made up of content blocks. The content blocks can be reorganized, updated, and customized according to regulatory objectives and regional filing needs. The structured content and data library can achieve flexible output options, including electronic data submission, cloud-based information transfer, and printable paper-based filings