The SagaReg Platform: AI-Powered Dossier Automation
​Our platform leverages fine-tuned Large Language Models (LLMs) and Retrieval-Augmented Generation (RAG) to continuously draft, update, and verify dossier content as new data emerges throughout the drug development lifecycle.
Key Features
1 / Continuous Dossier Generation
Unlike solutions focused on workflow management, SagaReg actively generates and updates content in real time, ensuring compliance as new data becomes available.
2 / RAG for Data Integrity
Our platform ensures AI-generated content is traceable to original data sources, enhancing transparency and regulatory trust.
3 / Automated Compliance Adaptation
AI-driven templates adjust dynamically to meet varying regulatory requirements, streamlining dossier standardization across jurisdictions
4 / AI-Powered Summarization and Validation
By integrating LLMs with traditional validation software, SagaReg enhances accuracy, reducing human errors and ensuring data consistency.
5 / Real-Time Dossier Tracking
A dynamic dashboard provides an overview of completed and pending sections, improving efficiency and decision-making.
Technical Foundation
SagaReg's solution integrates state-of-the-art advancements in machine learning, NLP and regulatory compliance
Fine-Tuned
LLMs​
Utilizing advanced transformer architectures for high contextual understanding
Retrieval-Augmented Generation
Combining LLMs with vector search technologies to ensure data accuracy
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AI Rule Engines
Using knowledge graphs to align with global regulatory requirements
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Cloud-Native
Architecture
Built with enterprise-grade security and scalability
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Continuous
Learning
Implementing secure, privacy-preserving AI model improvements
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