The AuroraPrime AI Platform is a tool for regulatory document creation, specifically designed to automate the authoring of critical regulatory documents such as DSURs, PSURs, ICSRs, Patient Safety Narratives, and more. By streamlining end-to-end authoring workflows across these documents, AuroraPrime enhances efficiency, ensures compliance and accuracy, and significantly accelerates timelines for life sciences enterprises.
AuroraPrime RMA is an AI writing solution for life sciences designed to revolutionize how organizations create and manage their regulatory documents. This software streamlines the entire process, from authoring to submission, increasing efficiency and ensuring compliance.
AuroraPrime RMA provides automated support for regulatory documentation, including:
Development Safety Update Reports (DSUR)
Periodic Safety Update Reports (PSUR)
Individual Case Safety Reports (ICSR)
Summary of Product Characteristics (SmPC)
Other Regulatory Documents
AuroraPrime’s regulatory document writing tool is enhanced with AI-powered translation that ensures industry-standard quality. This solution offers customizable memory, multi-format support, and cross-file consistency.
Our AI-powered regulatory document translation software leverages a customizable translation memory and terminology dictionary. The AI continuously improves the system by learning from past translations, enhancing accuracy over time.
This automated solution seamlessly handles various regulatory documentation file formats, including DOCX, PDF, PPTX, and XLSX. It also supports multiple languages, streamlining global regulatory submissions.
AuroraPrime’s AI-enabled tool maintains consistent terminology and style across all project documents. This ensures clarity and accuracy in translated regulatory documents, which is essential for compliance.
AuroraPrime's AI-powered writing tool automates the creation of DSUR and PSUR, streamlining data integration, analysis, and regulatory drafting. This process is enhanced by dynamic literature intelligence, cross-functional workflows, and real-time compliance updates, significantly reducing submission timelines.
AuroraPrime's AI writing tool automates data aggregation from multiple sources, accelerates risk analysis, and drafts DSUR narratives. This regulatory document writing software also ensures alignment with current regulatory guidelines, improving efficienc
AuroraPrime's AI writing software automates PSUR generation by synthesizing safety data, automating periodic benefit-risk evaluations, and streamlining reporting. It also enhances accuracy and speeds up submissions.
Our AI-powered medical writing solution accelerates patient safety reporting with efficient data handling, rapid templates, seamless system integration, and automated multi-source data extraction. This reduces prep time while ensuring compliance and productivity.
Generate the first draft within 1 minute
Create batch drafts within minutes
When using our AI writing tool, you can begin by browsing through AuroraPrime's library of pre-built templates designed for various regulatory documents. These templates provide a structured foundation, ensuring consistency and compliance from the outset for documents like DSURs and PSURs.
By leveraging AI and integration with Veeva RIM, AuroraPrime automates content creation by synthesizing upstream documents and data. This enables rapid generation of comprehensive drafts, significantly reducing manual effort.
With our regulatory document workflows, our AI software can facilitate seamless collaboration among teams. The platform enables real-time review, editing, and feedback, ensuring all stakeholders are aligned throughout the document lifecycle.
Streamline the finalization and submission process of regulatory documentation with AuroraPrime's automated tools. The system ensures documents are complete, compliant, and ready for submission to regulatory authorities, reducing delays and errors.
AuroraPrime significantly accelerates the regulatory documentation process. By providing automated support, this tool reduces drafting time for critical documents like DSURs and PSURs. Like our AI-powered medical writing solutions, AuroraPrime also streamlines workflows, enabling faster submissions and quicker access to the market.
AuroraPrime provides comprehensive, end-to-end automation of regulatory document creation. From template initiation to final submission, this AI software automates each step, ensuring a seamless and efficient process.
AuroraPrime embeds regulatory intelligence into the document creation process. Additionally, this AI writing software ensures that all documents adhere to the latest regulatory guidelines and standards, minimizing compliance risks and ensuring accurate submissions
Pre-built templates designed for various regulatory documents provide a structured foundation, ensuring consistency across the company.
Our AI content authoring tool speeds regulatory document drafting with smart templates, auto-data extraction, and seamless integration.
Ensure regulatory compliance with AuroraPrime's built-in compliance check functionality.
