2025

Automation now the only option: Regulatory AI investment a 2025 priority due to untenable workloads, survey confirms

by cyb2025

AGNES CWIENCZEK
Director of Product Management, ArisGlobal, Croatia

ABSTRACT

Three in five life science regulatory professionals are now experiencing an increase in day-to-day work throughput that far exceeds what would be expected with company growth. A new survey of senior regulatory professionals at US pharma/biopharma organisations identifies a direct correlation with planned AI investment – now seen as their best bet to stay on top of escalating workloads. Yet closer analysis also reveals that attitudes to AI’s suitability in a regulatory context may need updating. ArisGlobal’s Agnes Cwienczek unpacks the findings.

If the pharma/biopharma industry is to maximise affordable access for patients and maintain commercial viability as products grow ever more sophisticated, companies must become smarter in how they allocate resources to routine R&D processes, including regulatory workloads.

It is in this context that organisations are turning towards artificial intelligence (AI), and in particular next-generation technologies such as Generative AI (GenAI) powered by large language models (LLMs) – albeit that there often remain questions they need to resolve first. To understand the evolving balance between AI appetite and barriers to adoption, we recently commissioned a survey, by Censuswide, with 100 senior regulatory professionals in US pharma and biopharma organisations.

 

Regulatory inefficiency is spiralling

ABOUT THE AUTHOR

Agnes Cwienczek is Director of Product Management at ArisGlobal, specialising in Regulatory Information Management, Document Management, Submission Management and Labelling Management.

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