Leveraging AI For Regulatory Excellence
The regulatory landscape is becoming increasingly complex, particularly in the realm of CMC (Chemistry, Manufacturing, and Controls) dossier submissions. With new global standards like KASA, IDMP, PQ/CMC and FHIR, regulatory teams are facing greater complexity and business challenges.
Artificial intelligence (AI) is proving to be the cornerstone in automating CMC dossier creation. By harnessing advanced Data Science capabilities and AI, regulatory teams can automate repetitive, data-heavy tasks, freeing valuable resources to focus on critical decision points.
By automating data flows, AI doesn’t just streamline workflows; it transforms how regulatory teams approach dossier creation.