Regulatory Submission Lifecycle Management in the Global Pharmaceutical Industry

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Prof. (Dr) David Brown

School of Computing and AI

University of Edinburgh Global Campus, UK

Abstract— Efficient regulatory submission lifecycle management (RS-LCM) has become a strategic imperative for pharmaceutical companies amid accelerating global product pipelines and increasingly complex regional regulations. This manuscript explores contemporary RS-LCM practices, focusing on electronic Common Technical Document (eCTD) v4.0 transitions, digital-first dossier assembly, and data-driven variation tracking. Drawing on recent agency guidance, industry surveys, and a multi-region quantitative analysis, we examine how structured content and data management (SCDM) platforms, artificial intelligence (AI) tools, and harmonised quality systems shorten submission preparation time, improve right-first-time metrics, and lower compliance risk. A five-region data set (2018-2023) illustrates statistically significant correlations between proactive lifecycle strategies and both approval speed and post-approval variation turnaround. We propose an integrated methodology that blends regulatory intelligence feeds, template-based authoring, and cross-functional operating models to deliver “submission-ready” dossiers in near real time. Findings suggest that organisations embracing end-to-end digitalisation can reduce total cost of regulatory ownership by up to 27 percent while boosting on-time agency interactions. The paper concludes with practical recommendations for scaling RS-LCM, supported by 20 current references and an original statistical analysis.

Keywords

Regulatory lifecycle management, eCTD v4.0, pharmaceutical submissions, digitalization, variation tracking, regulatory intelligence

References

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