Zifo Technologies unveils new AI-based document authoring platform to support science organizations in speeding up the way they submitted regulatory submissions. The new platform collapses the time needed to compile a first draft of key regulatory documents from several days to just a couple of hours, and also adhere all compliance protocols. The solution is designed to meet the demands of both simple and complex documentation such as CSRs, Investigator Brochures and CMC submissions.
It leverages LLMs and AI-assisted templates to generate drafts from structured and unstructured data and validates the output with dynamic compliance assessments. Zifo believes the technology effectively solves several long-standing pain points faced by regulatory writing teams like laborious drafting, inconsistent formatting, disaggregated data sources and under capacity team members in high volume submission cycles.
With automation, writers can free up time by removing monotonous documentation tasks so they can direct their time to higher-value scientific and strategic work.
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Zifo’s platform is unique in the sense that while other AI tools for writing are made for general usage, Zifo’s solution is created for the regulatory and scientific world. According to the company’s statement, it removes the “transcription limbo” through the use of standardized templates together with AI-produced content that is always traceable and verifiable.
Another important feature of this platform is the utilization of explainable AI technology. In this regard, each piece of generated information comes with linked sources as well as metadata which ensures that the generated content is audit-ready and regulatory-compliant. Human experts are always in full control and can make edits, regenerations, or accept the output from the tool.
Moreover, the solution offers flexible deployment options since companies can decide whether to deploy the solution on the premises or in a private cloud environment depending on their data privacy and security needs.
Finally, the launch of Zifo‘s AI content generation solution is not limited to regulatory affairs since it can be used throughout the scientific workflow – from pre-clinical studies, clinical trials, up to pharmacovigilance activities.