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AI in Regulatory Affairs Harnessing Next-generation Tech to Drive Efficiency and Productivity

The pharmaceutical industry is significantly transforming, driven by escalating R&D costs, rising competition, and a rapidly evolving global regulatory landscape. In this dynamic environment, regulatory affairs have emerged from their traditional compliance-focused roles to become strategic business agility enablers. Enterprises are increasingly recognizing the potential of AI, generative AI, and agentic AI to reduce manual workloads, accelerate time-to-market, and improve the accuracy and consistency of regulatory submissions.

This report provides comprehensive insights into AI adoption’s current state in regulatory affairs, highlighting key challenges, value drivers, and investment trends. It explores prioritized strategic and operational use cases across regulatory processes and outlines how enterprises can overcome adoption hurdles through robust governance frameworks.

The report also examines specialized providers’ evolving role in this transformation. Through their domain expertise, technology capabilities, and scalable solutions, these providers help reduce risk, ensure compliance, and enable faster time-to-market.

Industry

Life Sciences BPS

Geography

Global

Contents

In this report, we examine:

  • Regulatory affairs’ evolving role in life sciences
  • Current and future AI investment trends across pharma enterprises
  • Leading AI use cases in regulatory strategy and operations
  • A governance framework to address AI adoption challenges
  • The strategic role of regulatory affairs specialist providers in accelerating AI adoption

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