Compliance from commit one. Not from the audit letter.

The window between “we'll fix it later” and the $2M remediation sprint is shorter than founders think. Series A due diligence, FDA 510(k), FCA authorisation, SOC 2 Type II — compliance gaps kill deals and delay launches. The founders who survive are the ones who built it right the first time.

The Standard Path

Month 1

Build fast. Compliance is a later problem.

Month 6

Architecture locked in. PHI flowing unlogged.

Month 14

Audit letter. Due diligence opens. FDA review begins.

Month 18

$2–4M remediation sprint. Deal on hold. Launch delayed.

Why It Fails

The standard path is a trap.

Build fast, add compliance later. It sounds like a reasonable trade-off until you understand what “later” actually costs. Architecture decisions made in month 1 determine your compliance bill in month 18. PHI data flows, access controls, and encryption boundaries cannot be retrofitted onto a live production system without rebuilding it. That rebuild costs 2–4× the original build and takes longer than the original build did.

01 The Audit Letter Problem

The OCR investigation or SOC 2 auditor letter arrives 14 months after launch — after the architecture is set, after the data is live, after the cost of change has compounded. Architecture decisions made in month 1 determine your compliance bill in month 18.

02 The Series A Kill Shot

1 in 3 Series A deals is delayed or killed by compliance gaps discovered in due diligence. The data room opens, the buyer's technical team runs a security questionnaire, and the gaps that were always there become the reason the valuation drops 30%.

03 The FDA / FCA Wall

FDA 510(k) and FCA authorisation both require software documentation written to a standard that was not designed after the fact. Pre-submission meetings get cancelled when the technical file doesn't exist. These are not gaps you can close in a weekend.

What We Build

Three tracks. One principle.

Every track is fixed price, fixed scope, and ends with a production system — not a report. Choose the track that matches your stage.

01 Compliance Foundation

Pre-Series A
8–12 weeks · Fixed price
HIPAA baseline, SOC 2 Type I readiness, and GDPR data model built into your architecture before a single audit letter lands. We design the data flows, access controls, and encryption boundaries from the first sprint.

  • HIPAA Security Rule technical safeguards mapped to code
  • PHI data flow diagrams + BAA templates
  • GDPR-compliant data model and retention policies
  • SOC 2 Type I readiness assessment and gap closure
  • Incident response plan and runbooks

Deliverable: Compliance-certified architecture. Audit-ready documentation. SOC 2 Type I report.

02 Scale Track

Series A / Series B
Ongoing · Fixed scope per phase
Full SOC 2 Type II, FCA or FDA pre-submission readiness, and enterprise security posture. Built for founders who are about to enter due diligence and need the gaps closed before the data room opens.

  • SOC 2 Type II — 6-month observation period support
  • FCA authorisation technical file preparation
  • FDA 510(k) pre-submission software documentation
  • Enterprise security posture and penetration testing
  • Vendor risk management and third-party BAA programme

Deliverable: Enterprise-ready. Due-diligence-ready. Audit-ready.

03 Regulated Product Build

Regulated-Industry Founders
Fixed price · Fixed scope
For founders who want to build the product and the compliance simultaneously. EHR integrations, clinical decision support, fintech APIs — built compliance-native from the first commit, not retrofitted after the audit letter.

  • EHR integrations (Epic, Cerner, HL7 FHIR) — HIPAA-native
  • Clinical decision support — FDA SaMD pathway from day one
  • Fintech APIs — FCA or SEC-compliant by architecture
  • ALICE compliance gate in your CI/CD from week one
  • Full IP transfer on delivery — no vendor lock-in

Deliverable: Production system with compliance baked in. Not bolted on.

Due Diligence

Compliance gaps that kill Series A deals.

The data room opens. The buyer's technical team runs the security questionnaire. The gaps that were always there become the reason the valuation drops — or the deal dies. These are the eight most common killers.

  • No SOC 2 report
  • PHI stored without audit logs
  • No encryption at rest/transit documentation
  • No incident response plan
  • Vendor contracts with no BAAs
  • GDPR data maps missing
  • No penetration test evidence
  • Access controls not documented

Not a Consultancy

We build the systems. Not the report.

The standard startup compliance path: hire a consultancy for an $80,000 assessment that delivers a 200-page report — and leaves.

That report sits in a Google Drive. The gaps it identifies are still open six months later because nobody built the systems to close them. The consultancy is long gone — onto the next engagement.

We are not a compliance consultancy. We are an engineering firm that builds compliance-native systems. Our deliverable is working code, production infrastructure, and audit documentation that was generated by the engineers who built the thing — not written by a junior analyst who never touched the codebase.