AI Regulatory Strategy

For life sciences and professional service providers in medical devices, drugs and biologics. Accelerate clinical trial and FDA approvals with AI built on decades on FDA expertise.

One Integrated Platform with Full FDA Support.

Get strategic framework optimized for your product and human-in-the-loop support. We’ll represent you in FDA meetings.

PLATFORM

We Give Lean Teams Superpowers

Deffai streamlines your clinical pipeline by providing AI-powered advisory work. We amplify your team and give them the confidence and speed for a successful drug market entry.

Draft documents & anticipate FDA feedback

Transform your regulatory strategy and optimize cost with our AI automation platform.

Customized Clinical & Go-to-market

We provide comprehensive go-to-market support integrating different teams including Regulatory and CMC.

The New Standard in FDA Approval

Deffai is the first AI-native platform built for biopharma critical decisions. From preclinical to commercial, we adapt to your ways of working and scale effortlessly with your team.

Ready to optimize your regulatory pathway?

Email us directly at info@deffai.com, or fill the form below.