Intelligent infrastructure for life sciences
Between the brilliance of discoveryand the precision of a regulatory submission.
Coralis Bio is the bridge. We’re building cloud-native, agentic AI-assisted software for the scientists, engineers, and regulatory teams developing advanced therapies from discovery toward the clinic.
There are hundreds of documents standing between a cell or gene therapy and the patients who need it. We’re building software to help the people who write them — and to make the process orderly.
The science going in is unpredictable, brilliant, prone to failure. The output has to be a drug product that is identical every single time. Coralis is the structured space in between — honest about what it knows, careful about what it doesn’t, and built as a peer to the people who put their names on the science.
What Coralis is building.
Who we are
A small team of CGT development leaders, engineers, and designers with decades of combined experience across FDA, EMA, and Health Canada programs. We’ve worked inside the kinds of companies we’re now building for.
What we’re building
Cloud-native, AI-assisted software built as a peer to the people who already do the work — helping small CGT companies make sense of their own programs, with a clear sense of what software should and shouldn’t decide.
Where we’re going
Private beta with a small group of design partners through 2026. We’re building deliberately, in close collaboration with the people who will use what we make.
Private AI. Isolated data. Your keys.
Coralis is built for organizations that cannot afford to compromise on data security. Client isolation, encryption, and access control are not features we added — they are structural properties of how the platform works.
Get in touchPrivate AI, never public
Your documents are processed by private, enterprise-grade AI models running on isolated cloud infrastructure. Never sent to public AI services. Never used to train models.
Per-organization isolation
Every client gets its own isolated database and its own encrypted storage container, with an encryption key unique to your organization. There is no shared data layer.
Single-region, infrastructure-as-code
All processing and storage occurs within a single secure cloud region. The entire infrastructure is defined in code, version-controlled, and fully auditable.
Auditable by design
AI queries, document processing events, and access patterns are logged for compliance and review. Every output carries its provenance.
Built by operators. More than software.
Coralis is led by Lara Ionescu Silverman, PhD, and Steve Goldenberg, with experience spanning cell and gene therapy development, regulatory strategy, tech transfer, scale-up, and software building. Early partners get more than access to the platform — they work directly with the scientists, engineers, and builders behind it.
We are a small, distributed team building the software we wished existed from the inside, and through 2026 we are working closely with a select group of early partners in a hands-on model shaped by real-world experience.
Built with early partners.
We’re working in close collaboration with a small group of early partners through 2026. If you’re a scientist, operator, press, or prospective design partner — we’d like to hear from you.