Coralis Bio provides cloud‑native, AI‑assisted software that streamlines the end‑to‑end workflow for advanced therapy development, from CMC process development and nonclinical study design to clinical trial strategy and regulatory submissions. The platform acts as a collaborative “peer” for scientists, engineers, and regulatory teams, helping small CGT companies organize data, capture undocumented expertise, and make informed decisions throughout discovery, manufacturing readiness, and FDA/EMA interactions.
Funding
Funding not disclosed
Founders
Product
Problem
Advanced therapy developers must navigate a fragmented workflow that spans discovery, process development, nonclinical studies, and regulatory submissions, each requiring extensive data organization, undocumented expert judgments, and compliant documentation. Small cell and gene therapy companies often lack integrated tools to manage this complexity, leading to delays, inconsistencies, and higher risk of regulatory setbacks.
Solution
Coralis Bio delivers a cloud-native, AI‑assisted platform that serves as a collaborative “peer” for scientists, engineers, and regulatory professionals developing advanced therapies. The software centralizes program data, captures tacit judgment calls, and automates the generation of FDA, EMA, and Health Canada‑compliant documentation across the entire development lifecycle. By structuring the decision space and providing analytics for CMC process development, nonclinical study design, and clinical strategy, the platform helps small CGT companies accelerate timelines while maintaining safety and consistency. The system is built to augment, not replace, expert input, ensuring that AI‑generated outputs are grounded in the evidence and context that matter for regulatory approval.
Target Audience
Primary users are small to mid‑size companies developing cell and gene therapies, including their scientific, process‑development, and regulatory teams that need an end‑to‑end, compliant workflow solution.
Features
- Cloud-native architecture that consolidates data from discovery, CMC, nonclinical, and clinical stages into a single, searchable repository
- Agentic AI assistance that captures undocumented expert judgments and suggests next steps while flagging areas lacking sufficient evidence
- Automated generation of compliant regulatory dossiers (BLAs, INDs, etc.) for FDA, EMA, and Health Canada, including traceability of decisions
- Integrated analytics for process development, manufacturing readiness, and translational study design to inform go/no‑go decisions
- Collaboration tools that enable real‑time interaction between scientific, engineering, and regulatory teams within the platform
- Secure, role‑based access and audit trails to meet data integrity and privacy requirements for regulated environments