Kalypsis provides an automated FDA compliance platform that continuously ingests and canonicalizes regulatory text, maps obligations to a company’s specific profile, and generates cryptographically sealed, shareable compliance snapshots.
Funding
Funding not disclosed
Founders
Product
Problem
Biotech and medical device companies often lack a continuously updated, auditable view of their FDA regulatory obligations, relying on manual monitoring or costly consultants. This leads to delayed detection of compliance gaps, costly remediation during audits, and increased risk during M&A, funding, or regulatory inspections.
Solution
Kalypsis offers an automated platform that continuously ingests FDA regulations, guidance, and CFR updates, converting them into a machine‑readable obligation graph. The system evaluates each obligation against a company’s specific profile—such as device class, development stage, and AI/ML usage—to identify real exposure. Results are compiled into cryptographically sealed, point‑in‑time compliance snapshots that can be shared via a single link, providing audit‑grade traceability and verifiable attestation history without consultant involvement. The platform maintains a tamper‑evident ledger with SHA‑256 hashing and chain integrity verification, ensuring that any change to obligations or attestations is instantly detectable. Users can access a precision‑grade review interface to view obligations, bindings, and attestation status, supporting regulatory audits, due‑diligence, and investor confidence.
Target Audience
Primary customers are biotech, medical device, and AI/ML‑enabled health technology companies that must maintain continuous FDA compliance, particularly those preparing for audits, M&A transactions, or investor due‑diligence.
Features
- CTSD Engine that transforms raw FDA CFR text into a deterministic obligation graph
- NLP‑driven Obligation Extractor with rule grammar to identify duty‑imposing sentences
- Canonical Normalizer that resolves defined terms and produces stable UTF‑8 strings for hashing
- SHA‑256 hashing and content‑derived IDs ensuring each obligation has a unique, immutable identifier
- Scope Resolver that automatically matches obligations to a company’s regulatory profile
- Snapshot Engine that seals the full set of obligations, bindings, and attestations into a single root hash
- Audit‑grade review interface with hash‑anchored attestations and 21 CFR Part 11 compliant electronic signatures
- External trust center link allowing investors, auditors, or regulators to verify compliance snapshots independently