Automation in Regulatory Document Compilation for ANDA Submissions

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Satyam Agarwal

Independent Researcher

Baraut, Baghpat, India

Abstract— The submission of an Abbreviated New Drug Application (ANDA) to regulatory agencies such as the U.S. Food and Drug Administration (FDA) necessitates the assembly of extensive technical, scientific, and administrative documentation. Traditionally, this process has been labor‐intensive, error‐prone, and time‐consuming, placing strain on both regulatory affairs teams and organizational resources. The introduction of automated document compilation platforms—leveraging rule‐based engines, natural language processing (NLP), and electronic Common Technical Document (eCTD) publishing tools—promises to streamline ANDA submissions by reducing manual effort, improving consistency, and accelerating time to market. This manuscript presents a comprehensive investigation into the development and deployment of automation in regulatory document compilation for ANDA submissions. It encompasses a systematic literature review, a description of the implemented methodology integrating data extraction, template management, and eCTD publishing, and a quantitative evaluation of the approach via error‐rate analysis and time savings metrics. Results indicate a 65% reduction in manual editing errors and a 40% decrease in compilation time. The discussion outlines the operational implications, challenges encountered, and future scope for AI‐driven enhancements. This work contributes actionable insights for pharmaceutical companies seeking regulatory compliance efficiency through automation.

Keywords

Automation, ANDA, regulatory affairs, eCTD, document compilation

References

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