Fully traceable Module 3 first drafts in hours with Asthra
Traditional CMC authoring is often thousands of pages long, built with critical data from development, manufacturing, QC and supply chain systems. As the primary source of evidence for a drug, accurate and traceable drafts are a non-negotiable.
Yet, authoring currently relies on manual compilation, driving long cycle times with risk of inconsistencies across Module 3 (CMC). How do we cut down on manual work, and enable QA and Regulatory Teams to focus on scientific judgement instead?
In this white paper, we explore the use of generative AI for a faster, fully traceable solution that changes the CMC authoring landscape for the better.
What you'll find inside:
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Why existing CMC authoring solutions are falling short, and how this can change
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Converting unstructured content into clean, structured inputs for downstream utilization
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How generative AI can take CMC dossiers from weeks to hours
