Best FDA submission AI tools

Cruxi is an AI-powered regulatory platform designed to streamline medical device submissions to the FDA and global authorities. It automates workflows for 510(k), De Novo, PMA, and more, significantly reducing preparation time and preventing common rejection issues.

An AI platform for clinical research that automates the generation of validation-ready SDTM and ADaM datasets. It dramatically reduces the time from database lock to FDA submission by handling complex programming tasks, allowing clinical teams to focus on high-value, study-specific logic while ensuring data security and HIPAA compliance.