RegFoundry
// The Integrated Compliance Development Environment

Design, validate, and deploy regulated workflows — powered by DAIN.

RegFoundry Studio is the AI-native ICDE powered by DAIN — the Domain-Aware Intelligence Network built for regulated life sciences. Design, configure, validate, and deploy regulated workflows in one AI-native environment.

Unlike a traditional AI development tool, RegFoundry Studio embeds requirements, controls, traceability, testing, and validation evidence throughout the development lifecycle.

Start a build Explore the compliance architecture
// What you do in the ICDE
  • →Build regulated applications and workflows
  • →Generate requirements and test protocols
  • →Maintain end-to-end traceability
  • →Produce validation evidence automatically
  • →Apply human review and approval controls
  • →Deploy directly into the RegForge GCP OS
// What DAIN and the RegEngine record

A traceable chain from intent to implementation — and from implementation to validation evidence.

Domain-aware intelligence

DAIN agents understand life-science requirements, controls, and quality-system expectations.

Governed model gateway

Classify, redact, minimize, and approve before any request leaves the sovereign environment.

End-to-end traceability

Requirements, risks, controls, code, tests, and approvals stay linked across the lifecycle.

Human review and approval

AI output is proposed work — reviewed, approved, and e-signed before it becomes a record.

Validation evidence by default

Protocols, executions, and evidence are produced as you build, not reconstructed afterwards.

Global regulatory pathways

FDA, MDR/IVDR, HIPAA, GDPR, MHRA, Health Canada, TGA, ISO 13485/14971, IEC 62304.

// Compliance architecture · interactive
click a node
governed path
policy control
// Control plane

RegEngine

The RegEngine governs every action — what may run, on what data, under which policy.

  • Applies organization policy, risk profile, and framework rules
  • Chooses the runtime, tools, and reviewers required
  • Emits a signed decision record for every dispatch
step
// Not a ticket queue. A Requirements Studio.

Build in real time — with compliance as a by-product.

Requirements are captured, configured, and built in the same environment, then deployed straight into the RegForge GCP OS. No backlog grooming, no sprint planning, no engineering-heavy handoffs between the people who know the regulation and the people who write the software.

Start a build See the control architecture
// Use cases

Regulated workflows, built in days — with the evidence produced as you go.

Every build in RegFoundry Studio emits the same evidence spine: requirements, risk, tests, signatures and an audit trail an inspector can follow end to end.

Pharmacovigilance

Adverse Event intake & reporting portal

Safety teams collect AEs across email, call centre and site portals, then hand-reconcile them before regulatory submission clocks run out.

What gets built
  • —Intake forms with coded seriousness/causality fields
  • —Triage queue with escalation and due-date clocks
  • —E2B-ready case export and reconciliation view
Evidence produced
  • —User requirements (URS) and functional specs generated in the Requirements Studio
  • —IQ/OQ/PQ scripts with executed results and pass/fail evidence
  • —21 CFR Part 11 e-signature manifests on every approved case configuration
  • —Immutable audit trail of who changed what field, when, and why
Traceability chain
  1. 01Regulation
  2. 02requirement
  3. 03configuration
  4. 04test case
  5. 05executed evidence
  6. 06release record
Define
Requirements & risk
Validate
Tests & signed evidence
Deploy
Release & audit record
// Frequently asked

What an ICDE is, and how DAIN powers it.

Plain answers to the questions we get most from quality, regulatory, and engineering leaders in regulated industries.

An ICDE is an Integrated Compliance Development Environment. A traditional IDE is where software is written; an ICDE is where regulated software is specified, built, tested, approved, and evidenced in one place. Requirements, risks, controls, traceability, test protocols, and validation evidence are first-class objects in the environment — not documents reconstructed after the build.

// Request a demo

See the ICDE on your regulated workflows.

Tell us what you're building. We'll walk you through DAIN, the Requirements Studio, and how validation evidence is produced as you build.

Stored in the regulated record · never sold · GDPR-friendly