Intelligent infrastructure for life sciences
Clarity moves science forward.
Coralis is the AI-native platform for cell and gene therapy, drug, and biologic development. It connects the evidence, decisions, and expertise across your program, helping your team see what matters, act with confidence, and move promising therapies toward patients.
What we believe
There are hundreds of decisions standing between advanced therapy and the patients who need it. Coralis helps the people behind them be ready for every milestone and deliverable, with the end in mind.
- CMC
- Process development, analytics, and manufacturing readiness.
- Nonclinical
- Safety, pharmacology, and translational study design.
- Clinical
- First-in-human and pivotal study strategy for advanced therapies.
- Regulatory
- FDA, EMA, and PMDA engagement, INTERACTs through BLAs.
How it works
Any AI can generate outputs from prompts.
Coralis is prewired with specialized harnesses, agentic workflows, and outputs based on years of experience, so the output is both correct and useful.
- Ready: What can I defend today?
- Missing: Where might the evidence fail review?
- Why: How was this conclusion reached?
- Next: What must change while it is still affordable?
How we work alongside you
The important work is not writing the final document.
It is knowing what the document must contain, which depends on connections across functions. Coralis provides the tools to both do the work and see the connections.
Information capture
One repository for the entire program. The structure makes gaps and priorities visible at a glance.
Ontology + regulatory & guidance model
A world model for biotech development: requirements, relationships, and what depends on what. Public regulations, guidances, and precedents structured so agents can use them, with sources retained.
Agentic workflows + software harness
Self-service consulting deliverables through agentic workflows. Deterministic checks and controlled actions around the model, with human review at the beginning and end, as needed.
Deliverables and submissions
Accurate, cited document generation, including submission-ready files.
Built on private infrastructure
Private AI. Isolated data. Your keys.
Isolation, encryption, and access control are built into how the platform works, not added on.
How we protect your dataPrivate AI, never public
Private models on isolated infrastructure. Never sent to public AI services or used to train models.
Per-organization isolation
Your own database, storage, and encryption key. No shared data layer.
US-hosted, infrastructure‑as‑code
Stored in US East, backed up in a second US region, defined in version-controlled code.
Auditable by design
Every AI query, document event, and access is logged. Every output carries its provenance.
The team
Built by operators. More than software.
A small team of CGT development leaders, engineers, and designers with decades of combined experience across FDA, EMA, and PMDA programs. We’ve worked inside the kinds of companies we’re now building for.
Coralis is led by Dr. Lara Ionescu Silverman, and Steve Goldenberg, with experience spanning cell and gene therapy development, regulatory strategy, tech transfer, scale-up, software engineering, and agentic AI. Our partners get more than access to the platform — they work directly with the scientists, engineers, and builders behind it.
We have built a platform that already generates meaningful benefit to customers, with additional features rolling out over time.
Talk to us
Bring us your program.
Tell us where your program stands and what comes next. We’ll show you how Coralis maps the work ahead — and where your team signs off.