Autonomous regulatory exposure infrastructure —
not another compliance checklist.
Four distinct layers. One continuously updated record of what your company knew, when it knew it, and how it responded.
01Ingest & Monitor
02Exposure Computation
03Human Attestation
04Trust Center
Part 820 — Device quality system
12 new
Part 11 — Electronic records
3 new
Part 201 — Labeling
7 new
Part 830 — Device ID
2 new
Part 312 — IND applications
—
01
Layer one
Continuous 21 CFR
ingestion & monitoring
Autonomous jobs run twice daily, scraping the Federal Register and FDA databases. Every new amendment, guidance document, and 21 CFR Part update is ingested and canonicalized into machine-readable regulatory obligations — without you lifting a finger.
- Covers all relevant 21 CFR Parts based on your product profile
- Source-linked to Federal Register citations — fully auditable
- Structured into machine-readable obligations, not PDFs
- Expandable beyond FDA: DoD, FedRAMP, ISO frameworks coming soon
Regulatory profile
Class II Device
IND Stage
Uses AI/ML
Therapeutic
Phase I Trial
⚠ New exposure detected
21 CFR §820.198 (amended) — AI/ML complaint audit requirement now applies to your device class and AI usage. Action required.
✓ Not applicable — filtered out
21 CFR §606.100 (blood bank regulations) — Not applicable to your device class or therapeutic modality.
02
Layer two
Company-specific
exposure computation
Not every regulation applies to every company. Kalypsis evaluates each new obligation against your specific regulatory profile — device class, development stage, use of AI/ML, therapeutic modality, trial phase — and surfaces only what creates real exposure for you.
- Regulatory profile built once, updated as you grow
- Zero noise: only obligations that genuinely apply are surfaced
- AI/ML usage triggers automatic evaluation against new mandates
- Exposure deltas computed in real time as regulations change
01
Obligation flagged by system
Feb 12, 2026 · Automated
02
AI-generated structured review notes created
Feb 13, 2026 · AI-assisted
03
Human review — Dr. Sarah Chen, VP Regulatory
In progress · Identity-bound
04
Approval or denial with decision record
Pending human attestation
05
Cryptographic lock — snapshot updated
Permanent point-in-time record
03
Layer three
Human attestation with
cryptographic audit lock
The one thing that can't be automated is human judgment. When the system flags an obligation, your compliance lead reviews it, attests, and approves or denies. That decision is identity-bound, timestamped, and cryptographically locked — creating a permanent point-in-time record no one can retroactively alter.
- AI-generated structured review notes to accelerate human decision
- Identity-bound: every attestation tied to a specific authorized lead
- Approval moves obligation from pending to attested in your snapshot
- Point-in-time requests retrievable by auditors months or years later
Aureleim Therapeutics
Trust Center · FDA Compliance Posture
Verified ✓
Recent attestation activity
Feb 13, 2026
Attested
21 CFR §11.10 — Electronic records validation
Jan 28, 2026
Attested
21 CFR §820.100 — CAPA system requirements
Feb 12, 2026
Pending
21 CFR §820.198 — AI/ML complaint audit
04
Layer four
External trust center —
the SOC 2 for FDA compliance
Every time your team attests, the external trust center updates automatically. Share one link with investors, auditors, acquirers, or regulators. They see your live compliance posture, attestation history, and source citations — not a static PDF. No consultant required.
- Live compliance posture score, always current
- Full attestation timeline with Federal Register source citations
- Point-in-time snapshot requests — auditors can pull any past state
- Shareable via link — no login required for third-party viewers
01 · INGEST
Autonomous 21 CFR scraping
Twice-daily automated ingestion from the Federal Register — no manual monitoring required, ever.
02 · COMPUTE
Company-specific exposure delta
Only shows obligations that actually apply to your product class, stage, and regulatory profile.
03 · LOCK
Cryptographic audit lock
Every attestation creates a cryptographically locked, irreversible point-in-time record.
04 · AI
AI-generated review notes
Structured analysis of each new obligation to accelerate human review and decision-making.
05 · SHARE
Shareable trust center
One link for investors, auditors, and acquirers. Live compliance posture, no login required.
06 · EXPORT
FDA-format audit packages
Export compliance packages in the exact format FDA auditors require. No reformatting.
07 · ALERT
Real-time exposure alerts
Immediate notification when a new amendment creates exposure for your specific product.
08 · ACCESS
Role-based access
Internal and external access layers — control exactly who sees what and who can attest.
09 · EXPAND
Multi-framework expansion
FDA is the wedge. DoD, FedRAMP, and ISO frameworks are on the roadmap — same infrastructure.
Ready to see it live?
See a live compliance snapshot
in 20 minutes.
We'll show you exactly what Kalypsis surfaces for a company at your stage — no prep required from you.
Three buyers.
One problem.
Different urgency.
$250K–$1.2M
Warning letter cost
Average direct cost of a single FDA warning letter response — remediation, legal, and operational.
Weeks → Hours
M&A diligence time
FDA regulatory diligence typically requires weeks of document requests. Kalypsis delivers a point-in-time snapshot on demand.
Post-close
When gaps surface
When most compliance gaps surface without a trust layer — in diligence, after acquisition, or at FDA audit.
Starting your audit trail before you need it
Like a company building pelvic floor health tech — not approaching FDA yet, but in 3 years they will be. Starting an automated audit trail now, even partially, is infinitely better than having nothing when the day comes.
Approaching IND filing or first device submission
For companies approaching revenue with no automated way to track what they're compliant with. When the FDA arrives — and for Class II/III manufacturers it's mandatory every two years — reconstruction without an automated system means weeks of scrambling.
Raising capital and need to show compliance posture
Investors are starting to ask. Your answer shouldn't be "we have a consultant who tracks it." Share a live trust center link. Show them a compliance posture score. That's a real answer that closes rounds faster.
Acquisition diligence — see the full compliance history
Request a point-in-time snapshot of the target's compliance posture as of any date in their history. See exactly which obligations they attested to, when, who approved, and the source Federal Register citation. Locked, citeable, defensible.
Preventing acquisition haircuts from compliance gaps
Your client is acquiring a medtech company. During diligence, Kalypsis surfaces three unattested 21 CFR obligations from the past 18 months. That's a negotiation tool — or a deal-stopper — before close, not after.
Portfolio company monitoring for PE-backed firms
Law firms serving PE clients can monitor compliance posture across an entire portfolio via the Kalypsis platform. One dashboard, multiple portfolio companies, continuous visibility.
Pre-acquisition compliance due diligence
Before you close, request a Kalypsis compliance snapshot of your acquisition target. See their full FDA obligation history, attestation rate, and any open exposure — before it becomes a haircut in your deal model.
Equipping portfolio companies ahead of exit
Give your portfolio companies Kalypsis access 12–18 months before exit. When the acquirer runs diligence, your company has a living compliance record. That's a valuation multiplier, not a footnote.
Investor transparency before your next round
Investors in your LPs want to understand regulatory risk in your life sciences portfolio. Share a compliance posture dashboard across your holdings. Show that you have systematic visibility, not just founder assurances.
For founders
Design Partner
Early-stage biotechs building their first audit trail. Direct product input, reduced pricing, and a compliance record that grows with you. Limited spots.
Apply for a spot
Most common
For companies approaching FDA
Core Platform
Full 21 CFR monitoring, exposure computation, attestation workflow, and external trust center. Priced to replace $150–500/hr consultant hours, not add to them.
Get pricing
For diligence workflows
Diligence Access
For law firms and PE firms needing point-in-time snapshot access across multiple companies. Per-deal or portfolio-wide pricing available.
Talk to us
Let's find the right fit
Tell us where you are.
We'll show you what applies.
20-minute call. We'll walk through a live snapshot for a company at your stage and answer any questions about fit.