Life Sciences & Government

Compliance-Grade AI.Future-Ready Operations.

Regulated.tech partners with Life Sciences and Government organizations to design, deploy, and validate AI and automation systems that meet the most demanding regulatory standards — before the auditors arrive.

Industries we serve

Built for the most regulated environments on earth

Life Sciences

From patient engagement systems to Pharmacovigilance, we architect AI and automation solutions that are validated, audit-ready, and aligned with FDA expectations from day one.

CFR 21 Part 11GxPHIPAA

Federal Government

We help federal agencies and contractors modernize operations with AI-driven automation that meets the security, documentation, and risk management requirements of federal frameworks.

NIST 800-53FISMAFedRAMP

What we do

Specialized services for regulated industries

Validated AI Implementation

Design and deploy AI systems with full validation documentation — IQ, OQ, PQ — aligned to regulatory expectations.

CFR 21 Part 11GxP

Intelligent Process Automation

Automate complex, compliance-sensitive workflows without sacrificing auditability or control.

GxPFISMA

Compliance Architecture & Advisory

Strategic guidance on building technology stacks that satisfy regulatory requirements across the full system lifecycle.

NIST 800-53HIPAA

AI Governance & Risk Management

Establish governance frameworks, risk assessments, and audit trails for AI systems operating in regulated environments.

FISMACFR 21 Part 11

Why Regulated.tech

The only firm that only does this

100%
Regulated-industry focus
Zero
General IT engagements

Most IT consultancies treat compliance as a checkbox. We treat it as the foundation. Regulated.tech was built exclusively for Life Sciences and Government — we don't dilute our expertise across industries. Every engagement is led by practitioners who have built compliant digital transformation solutions that navigated FDA inspections, NIST audits, or federal security reviews. Our deliverables are designed to satisfy scrutiny, not just survive it.

Ready to build systems that regulators trust?

Let's talk about your compliance landscape and where AI and automation can move the needle — without creating new risk.

Schedule a Consultation

What's included

  • Review of your current compliance posture
  • Identification of automation and AI opportunities
  • A clear path forward — no obligation
Regulated.tech

Boutique IT consulting for Life Sciences and Government. Experts in compliance-grade Digital Automation and AI.

© 2026 Regulated.tech LLC. All rights reserved.

Regulated.tech LLC provides consulting services. References to CFR 21 Part 11, GxP, HIPAA, NIST, and FISMA are for informational purposes. Clients are responsible for their own regulatory compliance determinations.