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GenAI Regulatory & Medical Writing ToolsProducts
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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Projects
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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Overview
What is AuroraPrime RMA?
Backed by Microsoft, Google, and Nvidia, AuroraPrime is a next-generation AI platform revolutionizing the creation of regulatory and medical documents. Powered by a built-in clinical knowledge base, an AI and LLM workbench, and a flexible, secure infrastructure, our regulatory and medical writing software ensures high-quality, efficient document production.
- Clinical Study Report (CSR)
- Protocol
- Lay Summaries
- Investigator’s Brochure
- CTD Module 2.5 and 2.7
- And more…
How It Works
AuroraPrime simplifies the entire regulatory and medical documentation process through a powerful GenAI engine, intuitive workflows, and seamless integration into existing systems.
This is how ourAI platform for medical content authoringworks:
Flexible, Pre-built Templates
AuroraPrime offers customizable templates for medical writing automation—including Clinical Study Reports (CSRs) and Protocols—providing a structured foundation tailored to your specific requirements.
AI-Driven Drafting & Updates
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.
Automated Update Triggers
AuroraPrime ensures documents stay up-to-date by monitoring linked source materials. When upstream changes occur, the system automatically triggers revisions or new drafts, minimizing manual oversight and keeping deliverables current.
Collaborative Review & Version Control
The platform streamlines teamwork with built-in collaboration tools and version tracking. Clinical writers and stakeholders can efficiently review and refine drafts while maintaining alignment throughout the process.
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