SagaReg provides an AI-driven platform to automate the creation of pharmaceutical regulatory dossiers. This solution significantly reduces preparation time, accelerates drug approvals, and minimizes reliance on extensive writing teams. The platform ensures enhanced data integrity and streamlines global submissions by adapting automatically to FDA, EMA, and PMDA requirements.
Funding
Funding not disclosed
Founders
Product
Problem
The pharmaceutical industry faces a time-consuming bottleneck in regulatory dossier creation, often requiring 9-12 months to complete. This labor-intensive process delays drug approvals and necessitates large teams of writers and experts.
Solution
SagaReg offers an AI-powered platform that automates the creation, updating, and validation of pharmaceutical regulatory dossiers. The platform leverages fine-tuned Large Language Models (LLMs) and Retrieval-Augmented Generation (RAG) to continuously draft and update dossier content as new data emerges throughout the drug development lifecycle. By automating drafting, streamlining global submissions, and enhancing data integrity, SagaReg reduces dossier preparation time, increases compliance, and cuts costs. The platform adapts dynamically to meet varying regulatory requirements, streamlining dossier standardization across jurisdictions.
Target Audience
SagaReg's primary customers are pharmaceutical companies seeking to accelerate drug approvals, reduce regulatory submission costs, and enhance data integrity.
Features
- Continuous dossier generation, actively generating and updating content in real time.
- Retrieval-Augmented Generation (RAG) ensures AI-generated content is traceable to original data sources.
- AI-driven templates adjust dynamically to meet varying regulatory requirements.
- AI-powered summarization and validation enhances accuracy and reduces human errors.
- Real-time dossier tracking dashboard provides an overview of completed and pending sections.
- Fine-tuned LLMs utilizing advanced transformer architectures for high contextual understanding.
- AI Rule Engines using knowledge graphs to align with global regulatory requirements.