AI for regulatory affairs

From regulatory data to decision in days, not months.

Regulia is an AI-integrated regulatory affairs platform for biotech, pharma, medtech, and CROs. Draft, QC, and submit faster — every AI artifact traceable to its source and signed off by a human reviewer.

Start free trial

Demo login: dr.nash@helixtx.com
· password Demo!Password2026

AI modules

Agencies covered

40+

Biotech & pharma teams

SOC 2

Compliant

Built for regulatory teams

Everything you need to move a submission forward — and nothing you don't.

AI drafting with citations

Type B briefings, IND amendments, agency responses — drafted with full source attribution and confidence scoring. Every line traceable.

Explore drafting

Portfolio readiness

Real-time scoring across all programs. Spot risk shifts before they become missed deadlines. Live dashboards for execs and leads.

See dashboard

Human-in-the-loop

Every AI artifact requires a named human reviewer before submission. Audit log, e-signatures, and approval workflows built in.

Governance details

14-day free trial · no credit card

Stand up a regulatory affairs workspace in 60 seconds.

Bring your team. Connect Veeva, Slack, and your e-CTD tooling. Generate your first AI-drafted briefing this afternoon.

Start your trial