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APPLICATION OF ARTIFICIAL INTELLIGENCE FOR AUTOMATION OF REGULATORY DOSSIER PREPARATION (CTD/eCTD)

Year: 2026

Type: article

Abstract: The pharmaceutical industry operates under stringent regulations, requiring companies to submit comprehensive documentation for drug approval, marketing authorization, and post-marketing surveillance. The Common Technical Document (CTD) and its electronic version, eCTD, are standardized formats used globally to facilitate regulatory submissions across multiple regions. These dossiers contain vast volumes of information, including quality, safety, efficacy data, clinical trial results, and manufacturing details.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.19588826

Author: Sanjyot Jagtap*¹, Syed Shoaib Ali²

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDG: Industry, innovation and infrastructure

Open Access status: green

OpenAlex ID: W7154479831

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