AI-Powered Regulatory Medical Authoring

Streamlined Documentation Across the Product Lifecycle

From CSRs and Protocols to Safety Narratives and CMC, AuroraPrime RMA is the AI platform for medical content authoring purpose-built for every document in your regulatory and pharmaceutical submission. 

Clinical Study Reports (CTD Module 5, CSR)

AuroraPrime RMA is trusted by 5 of the top 10 global pharma companies, delivering source-grounded, ICH-compliant CSRs with 90% faster first drafts and 50% overall time savings. Our AI-powered writing tool reuses protocol, SAP, and TFL data to accelerate first drafts, keeps text and tables synchronized through changes, and runs targeted QC checks, with full source traceability across every statement and figure.

Study Protocol & Amendment

AuroraPrime RMA keeps protocol, ICF, SAP, and downstream documents aligned across the study lifecycle, delivering 90% reduction in first-draft time and 50% overall time savings in the document cycle. This AI writing software combines evidence-driven drafting grounded in protocol, ICF, and SAP source documents, and QC-embedded workflow orchestration to design studies faster and maintain standardized clinical data across amendments.

Clinical Summaries (CTD Module 2.7.3 and 2.7.4)

AI-Orchestrated Authoring from Key Messages to QC

AuroraPrime RMA is the clinical summary AI writing software that structures Module 2.7.3 Summary of Clinical Efficacy and Module 2.7.4 Summary of Clinical Safety around centralized key messages, tracing every statement to supporting evidence. The platform ingests source data, maintains live links, regenerates text, and recommends updates as evidence changes, supporting integrated, adaptive, evidence-driven authoring and QC.

Non-Clinical Overview and Summaries (CTD Module 4 and Module 2.6)

End-to-End AI-Orchestrated Non-clinical Authoring Workflow

Our AI writing tool standardizes non-clinical reports into structured abstracts, recognizes study types, auto-builds compliant M2.6 tables of contents, supports cross-study synthesis for M2.4, and cascades updates from Module 4 changes into summaries, eliminating manual rework across non-clinical documentation.

Quality Overall Summary (QOS) and CMC (CTD Module 2.3 and Module 3)

AI-Orchestrated CMC Authoring, From Shell to QC

AuroraPrime RMA is the AI CMC authoring software and QOS AI writing tool that orchestrates Module 2.3 Quality Overall Summary and Module 3 Quality content. It pre-configures compliant outlines, batch-generates evidence-anchored drafts, supports role-based reviews, and surfaces conflicting comments, preserving traceability from shell to QC.