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Capability

AI-assisted regulatory assessment

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States & provinces
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1 ai-assisted regulatory assessment supplier across 1 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

DEFFAI, INC.

SAN JOSE, CA

Deffai provides AI-assisted regulatory intelligence validated by former FDA reviewers. The company is built by former FDA reviewers and decision-makers across CBER, CDER, and CDRH with 100+ years of experience across cell & gene therapy, including mRNA, AAV, ADC, immunotherapies for vaccines, oncology, regenerative medicine and tissue engineering for medical device and combination products. Deffai is an independent firm and is not affiliated with the U.S. Food and Drug Administration.

FDA meeting representationFDA submission reviewregulatory strategy

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