Built for the most regulated environments on earth
Regulated.tech works exclusively with Life Sciences and Federal Government organizations — the two sectors where compliance failures carry the highest consequences and where generic IT consulting falls shortest.
From lab to launch, compliance-ready at every stage
Pharmaceutical, biotech, medical device, and CRO organizations operate under some of the most demanding regulatory frameworks in the world. We architect AI and automation systems that are validated, audit-ready, and aligned with FDA expectations from day one — not retrofitted after the fact.
Patient Engagement
Intelligent enrollment and patient assistance platforms built for HIPAA and 21 CFR Part 11 compliance. Intent-led, guided workflows automate documentation, eligibility checks, and follow-up tasks — so agents stay focused on the patient conversation, not the system.
Pharmacovigilance
Intelligent automation for PV intake and case processing, with AI-driven detection of unreported SAEs surfaced directly from patient and HCP conversations. Built for FDA adverse event reporting compliance and validated for integration with Oracle Argus, Veeva Vault Safety, and ArisGlobal LifeSphere.
Regulatory Submissions
Intelligent document assembly and submission workflow automation aligned to FDA eCTD requirements.
Intelligent Process Automation
You know your processes — we know automation and compliance. Bring us your bottlenecks, your manual workarounds, your pain points. We'll design validated, regulation-ready solutions to automate and optimize them, without adding compliance risk.
Modernizing federal operations without creating new risk
Federal agencies and contractors face a unique challenge: modernize with AI and automation while satisfying the security, documentation, and risk management requirements of federal frameworks. We've done this work — not as observers, but as accountable practitioners.
Agency AI Modernization
AI strategy and implementation for federal agencies navigating OMB AI policy, NIST AI RMF, and mission-specific requirements.
Intelligent Process Automation
Workflow automation for procurement, HR, compliance reporting, and mission operations with FISMA-aligned audit trails.
Security Architecture
AI system design that satisfies NIST 800-53 control families and supports ATO documentation packages.
Contractor Compliance
Compliance architecture and advisory for civilian government contractors navigating FedRAMP, FISMA, and agency-specific requirements — ensuring your systems meet federal standards without slowing down delivery.
Why exclusivity matters
Depth over breadth — every time
Most IT consultancies serve every industry. That means their regulated-industry practitioners are a specialty practice within a generalist firm — outnumbered, under-resourced, and competing for senior talent against more profitable commercial engagements. Regulated.tech has no commercial clients to compete with. Every practitioner, every methodology, every deliverable template is built for regulated environments. That's not a positioning statement — it's a structural advantage.
- No dilution of expertise across unrelated industries
- Deliverable templates built to regulatory standards, not adapted from commercial frameworks
- Practitioners who have been on the other side of FDA inspections and NIST audits
Operating in a regulated environment?
Schedule a consultation to discuss your compliance landscape and where AI and automation can move the needle.
Schedule a Consultation