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AI-Powered Regulatory Dossier Automation
The pharmaceutical industry faces a critical bottleneck in regulatory dossier creation—a labor-intensive process that can take 9-12 months, delays drug approvals, and requires large teams of writers and experts.
SagaReg isn't just improving regulatory writing - it's redefining it
At SagaReg, we're revolutionizing this process with an AI-driven solution that dramatically reduces preparation time, increases compliance and cuts costs.
Acceleration
50% reduction in dossier preparation time, accelerating drug approvals and market entry
Compliance
Enhanced data integrity and compliance, reducing costly regulatory queries
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Efficiency
Significant cost savings by minimizing reliance on large regulatory writing teams
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Automation
Streamlined global submissions with automated adaptation to FDA, EMA, and PMDA requirements
Benefits
Reduced Manpower Requirements
Fewer technical writers needed due to automated drafting and reduced review cycles
Faster Approvals
More consistent, structured submissions may reduce regulatory review time
Enhanced Data Integrity
Comprehensive verification for both numerical and textual data
Global Compliance
Templates adapt to different regulatory authorities, simplifying standardization
Cost Savings
Significant reduction in resource allocation and consultant costs
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