AI-Powered Study Design

Design FDA-Aligned Studies
in Minutes, Not Months

Reg.AI guides biotech researchers through structured study design, providing real-time regulatory recommendations backed by FDA guidance and scientific literature.

Regulatory Intelligence at Your Fingertips

From study design to submission-ready outputs

FDA-Aligned Recommendations

Every recommendation is grounded in FDA guidance documents and ICH guidelines, with citations for full transparency.

AI-Powered Design

Advanced AI generates comprehensive study designs including sample size, endpoints, and statistical considerations.

10x Faster Workflows

What traditionally takes weeks with consultants now takes minutes. Iterate rapidly with version control.

Red Flag Detection

Automatically identifies potential regulatory concerns and provides recommendations to address them proactively.

All Modalities Supported

From small molecules to gene therapy, cell therapy, and vaccines. Tailored guidance for each modality.

Interactive Chat Assistant

Ask follow-up questions about your study design. The AI assistant provides context-aware answers.

Ready to streamline your study design?

Join biotech teams using Reg.AI to design FDA-aligned studies faster.