End-to-end regulatory document automation for biotech & pharma — powered by AI, backed by deep human domain expertise. From months of manual work to expert-review-ready documents in hours, while you focus on strategy.
AI is transforming industries and the era of manual writing ends now. AI4RA is on a mission to disrupt Regulatory Affairs and help early stage biotech companies bring innovation to patients faster.
Turn months of drafting into hours of expert review.
AI does the drafting, experts do the regulatory thinking.
Reduce documentation costs and internal resource burden.
AI does the drafting, experts do the regulatory thinking.
AI4RA combines domain-grounded automation with the controls needed for regulated regulatory work.
Structured, repeatable outputs grounded in source data. Secure multi-tenant architecture lets you switch to the best models as they emerge — without rebuilding the platform.
AI acts as a force multiplier. Regulatory professionals retain oversight, review every output and make the final decisions.
Multi-tenant isolation, EU data residency and controls designed for regulated life-science environments.
Navigate a complex regulatory landscape with confidence.
Streamlined regulatory without the overhead of a large team.
Extend your offering and handle more submissions.
The path to approval mapped from day one — target product profile, designation strategy and filing sequence.
Rare-disease dossiers and agency briefing packages built on the evidence you already have.
Living clinical and quality documents that stay current as data emerges.
Protocols, amendments, investigator updates and agency correspondence prepared with precision.
Quality, manufacturing, control strategy and stability sections ready for review.
The full submission package that carries you to approval across major regions.
These are the first high-value documents pilots are running with AI4RA.
Agency meetings prepared with precision, not panic.
Rare disease dossiers built on the evidence you already have.
The path to approval, mapped from day one.
One living document, always current.
More use cases coming — IND/CTA applications, Clinical Trial Protocols and Module 2 summaries.
"AI4RA is the tool we needed but couldn't find."
We didn't just study the workflow; we lived it. We don't just automate — we speak your language and respect your workflows. Anna's regulatory leadership spans early academic discovery through pivotal trial, with direct experience in glioblastoma, complex oncology and immuno-oncology, immunotherapy and neurodegenerative disease. Her work has taken her across seven countries — Sweden, Norway, the UK, the US, Switzerland, the Netherlands and Germany.
LinkedIn profileAI4RA is part of UnternehmerTUM and TUM Venture Labs Healthcare, recognized by the Financial Times as Europe's leading startup incubator three years in a row — as well as the Co-Ax accelerator by Sahlgrenska Science Park, one of Sweden's leading life science hubs.
Run your next authority meeting briefing package, regulatory strategy or Orphan Drug Designation with AI4RA — with significant early pilot benefits.