In 2024, pharma and biotech companies face rapid shifts in safety and compliance, driven by AI, ML, and NLP integration. Generative AI is expected to streamline regulatory intelligence, literature reviews, and predictive analytics while supporting efficiency in PV and regulatory submissions. FDA’s diversity plans are reshaping trial design, demanding more representative populations. Global regulatory divergence poses challenges, requiring strong local expertise and adaptable documentation processes. Companies are moving toward integrated tech-service models, with AI chatbots supporting but not replacing human engagement. The focus remains on balancing innovation, compliance, and patient safety.

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