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Documentation at Scale: Automating CMC Dossier Assembly and Traceability

Author(s) Pawankumar Suresh
Country India
Abstract The increasing complexity of Chemistry, Manufacturing, and Controls (CMC) dossier submissions poses greater challenges towards regulatory compliance, traceability, and effective content management in the pharmaceutical and biopharmaceutical industries. Conventional document-centric methods tend to yield redundant authoring tasks, long review cycles, and greater regulatory risks. In this study, automation, structured content management, and ontology-based frameworks are investigated as they simplify CMC dossier compilation while maintaining regulatory compliance and data integrity. Based on recent developments in structured data management solutions, regulatory information management systems, and knowledge management platforms, the paper points to digital transformation's impact on minimizing manual labor and allowing dossier preparation scalability. Case studies and industry reports show quantifiable decreases in authoring and review time, better traceability in global submissions, and better collaboration among cross-functional regulatory, clinical, and manufacturing teams. In addition, integration of ontologies and structured content supports global submission harmonization across regulatory regions, meeting global submission needs. The results emphasize the promise of automation and semantic technologies in enabling a compliant, future-ready, and streamlined regulatory environment for CMC dossier management.
Keywords CMC dossier automation, governed content, regulatory compliance, knowledge management, ontology-based traceability, dossier assembly, regulatory information management, pharmaceutical submissions, CMC digital transformation, biopharmaceutical compliance
Field Medical / Pharmacy
Published In Volume 3, Issue 9, September 2022
Published On 2022-09-09
Cite This Documentation at Scale: Automating CMC Dossier Assembly and Traceability - Pawankumar Suresh - IJLRP Volume 3, Issue 9, September 2022. DOI 10.5281/zenodo.17205211
DOI https://doi.org/10.5281/zenodo.17205211
Short DOI https://doi.org/g943m5
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