AI Regulatory Intelligence for Every Team

Assyro is the pharma regulatory AI that compresses submission cycles from weeks to days. AI-powered drafting, real-time eCTD validation, and traceable execution across every NDA, sNDA, and IND so your team ships faster without adding headcount.

Assyro is the biotech regulatory AI built for lean teams. If you have 3-5 people doing the work of 15, Assyro handles CRO coordination, eCTD assembly, and regulatory tracking so your team focuses on getting drugs approved, not formatting documents.

Assyro AI helps medical device companies navigate 510(k), PMA, De Novo, and global device submissions. From pre-submission preparation to post-market surveillance, our AI platform covers the complete device regulatory lifecycle.

Assyro is the AI for CROs that standardizes regulatory execution across every sponsor program. Deliver more submissions at the same quality bar without adding headcount, and onboard new staff in days instead of months.

Assyro is the CDMO regulatory AI that builds Module 3 packages with built-in validation and GMP compliance tracking. Stop losing weeks and margin every time a sponsor sends CMC documentation back for revisions.

Assyro is the regulatory consulting AI that lets solo consultants and small firms manage 15+ client programs from one dashboard. AI-assisted drafting, automated regulatory intelligence, and reusable workflows so you bill for strategy, not document formatting.