The compliance/regtech market is already huge (tens of billions) and growing fast with double-digit CAGRs. There's room for niche, deep, high-value tools — compliance is broad, but many firms still lack tailored automation for specific regulatory regimes (FDA, AI Act, etc.).
~$30.20B (2023)
~10.2% CAGR
~$17.02B (2023)
To ~$70.64B by 2030 (≈23.1% CAGR)
$36.1B (2021) → $60.7B (2026)
≈10.9% CAGR
$83B (2023)
$207B by 2028 (124% increase)
Automated compliance / GRC platform. Supports SOC 2, ISO 27001, HIPAA, GDPR, NIS2, etc.
They pull logs, monitor controls, help with audit readiness
They don't appear to focus on FDA-cyber premarket or AI Act style regulatory submission packs
Best compliance automation software that automates tests across health tech, fintech, SaaS, multiple frameworks
Multi-framework, automation of tests & controls
Likely not deep in domain-specific regulatory submission generation (e.g. SBOM + technical documentation + regulatory text)
FDA compliance software / quality & regulatory technology for life sciences
Focus in life sciences / regulated industries, FDA rules
They tend more toward QMS & regulatory process management rather than fully automated controls + evidence pipelines
GRC / regulatory compliance software (including FDA compliance)
Strong in compliance process / audit workflows
Doesn't emphasize continuous evidence collection + control automation + module-based regulatory packs
Enterprise QMS integrating FDA, ISO, ISO + audit readiness in regulated industries
Good regulatory / process / audit features
More on quality management, document workflows, less on automated technical evidence connectors
AI compliance platform that references "automated, real-time, FDA-ready" claims
They are attempting the kind of real-time / AI compliance angle
Underspecified whether they support full submission packs, control libraries, continuous connectors across domains
SaaS QMS + compliance workflows for FDA, ISO, OSHA etc.
Process, document control, audit workflows
Less of a technical "pull evidence from your systems and generate regulatory packages automatically" play
✓ Saved hundreds of hours and reduced time by over 80% vs doing it manually for SOC 2
Gap: Not handling FDA/AI Act level regulatory submission packs
✓ Audit prep workload dropped from 60-70 hours to ~3 hours/year (≈80-90% reduction)
Gap: Traditional GRC frameworks (SOC 2, etc.), not specialized regulatory submission generation
✓ Over $100K in annual savings for ISO 27001 compliance
Gap: No evidence of domain-specific regulatory submission or "FDA cyber" style
✓ Fast-tracked regulatory success and eliminated lag points in inspections
Gap: Process & documentation side only, not automated evidence pulling from cloud/SaaS/security tools