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The following is an excerpt from an article published on

GenAI is on the precipice of breaking new ground in regulatory intelligence; making strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.

Large Language Models (LLMs) are the foundation behind GenAI and have become the topic of the year in 2023. In the Healthcare and Life Sciences sectors, it’s been a game changer for advancing new medicines and ushering in a new renaissance in the pharmaceutical industry. While traditional AI was used to speed the development of the lifesaving COVID-19 vaccine1, GenAI is having an impact on many other areas across the R&D and Commercialization value chains. It is now on the precipice of breaking new ground in regulatory intelligence. A McKinsey report2 suggests that GenAI could unlock a potential value of about 2.6 to 4.5% of revenues ($60 billion to $110 billion) annually in the pharmaceutical and medical product industry.

Venkatraman “Bala” Balasubramanian, PhD,Senior VP and Global Head of Healthcare & Life Science

Historically, regulatory strategists and submission managers kept abreast of global regulatory guidelines and changes by searching Health Authority websites or scanning subscription databases. These professionals spend significant time and effort researching and summarizing regulatory guidelines and changes to understand and define regulatory pathways and strategies to prepare submissions in compliance with health authority regulations. Can GenAI alleviate these challenges by reducing manual effort and automating and streamlining regulatory research and submission processes, making them more productive and efficient?

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