Healthcare Technology
MED N EX  LABS

The compliance layer
pharma can’t
replace.

VMARAS is the cryptographic proof infrastructure behind pharmaceutical recall compliance. When a regulator asks “prove what happened” — organizations running VMARAS hand over a tamper-evident record that answers every question. Organizations that aren’t spend the next three weeks reconstructing spreadsheets.

N Audit Record · VMARAS Verified
Agentrecall-orchestrator-01
ActionFLAG_BATCH #RX-2024-881
Timestamp2025-03-14 09:22 UTC
Approved byCompliance Officer
Chain hashsha256:a3f9c8b2…
Chain integrity verified
PHI fields redacted
Regulatory export ready
< 5 min
end-to-end recall response with cryptographic proof chain
Class I–III
FDA recall classifications handled automatically with severity-based routing
100%
of recall actions recorded with tamper-evident, court-admissible proof
0 PHI
patient data exposed in audit exports — HIPAA-ready architecture by design
Why VMARAS becomes infrastructure
Mandate, not a choice

DSCSA mandates that pharmaceutical distributors prove verifiable recall response. The “should we buy this” question doesn’t exist — they have no choice but to have a solution.

The moat compounds

Every recall processed on VMARAS generates a cryptographic receipt. Every platform that embeds the proof chain makes it harder to displace. That’s not a product feature — it’s a position.

The standard, not a vendor

Enterprise platforms that don’t own a compliant proof chain will license one from someone who does. They aren’t buying a product — they’re buying the integrations and the cost of removing you.

⚠️
The Problem
Why regulated pharma needs a proof standard
🔐
VMARAS Platform
Capabilities, stack & 2026 roadmap
▶️
Live Demo
End-to-end recall in under 5 minutes
🏥
Target Markets
9 segments across the healthcare supply chain
📬
Partner / NDA
Platform, enterprise & integration partners
The Problem

Pharma distributors are legally mandated
to solve this problem. Most can’t.

Under DSCSA, pharmaceutical distributors must demonstrate verifiable, traceable responses to every drug recall. The mandate already exists. The enforcement is escalating. Most distributors are still doing it manually — spreadsheets, emails, and 33-hour average response times.

VMARAS processes the same recall in 45 minutes with a cryptographic proof chain their lawyers can use in court. That is not a productivity story — it is a legal liability story. One referenceable distributor customer changes every other conversation — with enterprise platforms, hospital systems, and investors.

33 hrs
average manual recall response time at a mid-size pharmaceutical distributor today
45 min
VMARAS end-to-end recall with cryptographic proof chain — under DSCSA mandate
$0
spent on discretionary purchase decisions — DSCSA makes this mandatory infrastructure
FDA 21 CFR §11
Electronic Records & SignaturesAudit trails, access controls, and e-signatures on AI decision events
HIPAA
PHI Handling & Audit ControlsBuilt-in PHI redaction and Security Rule §164.312(b) compliance
NIST AI RMF
AI Risk ManagementGOVERN, MAP, MEASURE, MANAGE function documentation support
EPCIS 2.0
Supply Chain TraceabilityRoadmap — DSCSA-compatible event export for lot-level recall traceability
USP <800>
Hazardous Drug HandlingAI decision chains for hazardous drug compounding and recall workflows
FedRAMP
Federal Cloud SecurityArchitecture aligned for VA, DoD, and IHS federal deployments
VMARAS Platform

Verifiable Agentic Recall Response

VMARAS is the proof chain infrastructure pharma platforms embed — not a point solution they evaluate. Built for pharmaceutical distributors mandated under DSCSA, and designed to become the proof chain that major health tech platforms cannot afford to build around.

CAPABILITY 01
Tamper-Evident Decision Records
Every AI agent action captured in a cryptographically linked audit chain — verifiable, timestamped, tamper-evident by design. Any modification is immediately detectable.
Full technical detail →
CAPABILITY 02
Human-in-the-Loop Enforcement
Configurable approval gates that pause agent workflows at defined risk thresholds. Every human authorization event is documented and cryptographically bound to the chain.
Full technical detail →
CAPABILITY 03
Regulatory-Ready Output
Audit artifacts structured for FDA 21 CFR Part 11 and HIPAA review — exported as structured JSON, human-readable PDF, and CSV. Inspectors read them directly without technical translation. FHIR R4 and EPCIS 2.0 integrations are on the 2026 roadmap.
Full technical detail →
CAPABILITY 04
Zero-Trust Architecture
PHI redaction, pluggable audit backends, air-gap compatible deployment. AES-256 encryption, RBAC enforcement, on-premise / private cloud / hybrid options.
Full technical detail →
2026 Roadmap Not yet in production
FHIR R4 / HL7 Export
EHR integration layer for major hospital EHR systems. Enables clinical-level interoperability once the integration layer is complete.
Q3 2026 target
EPCIS 2.0 Supply Chain
DSCSA-compatible event stream for pharmaceutical distributors and wholesalers. Lot-level traceability across the supply chain.
Q3 2026 target
HIPAA PHI Handling
Current version handles product-level data only. Full PHI processing capability pending BAA finalization and SOC 2 Type II audit.
Q4 2026 target
Live Simulation
Interactive Demo

End-to-end recall in under 5 minutes

Watch VMARAS process a simulated FDA Class II recall — from MedWatch ingest through cryptographic proof seal. Every step generates a tamper-evident audit record.

SCENARIO
FDA Class II Recall
Metoprolol Succinate ER
VMARAS Orchestration Engine Awaiting simulation
VMARAS v1.0 · MedNexLabs LLC · Patent Pending
── Press "Run Simulation" to begin ──
 
Audit Chain Status
📥
Block 001 Ingest
···
🤖
Block 002 AI Class.
···
🔒
Block 003 PHI Redact
···
👤
Block 004 Human Auth
···
🔐
Block 005 Quarantine
···
⛓️
Block 006 Proof Seal
···
✓ VMARAS Compliance Certificate Generated
Cryptographic proof sealed · Regulatory export ready · Court-admissible chain of custody
Recall EventFDA-2024-D-0881
ProductMetoprolol Succinate ER · Lot RX-2024-881-A
Quarantined147 units · 3 locations
Duration4m 22s end-to-end
Authorized byChief Compliance Officer
Root Hashsha256:7f3a9c2b8e1d4f06…
ExportsFDA 21 CFR §11 · HIPAA · JSON/CSV
Who We Serve

Built for the full healthcare & pharmaceutical ecosystem

Every organization across the regulated healthcare and pharmaceutical supply chain faces recall accountability requirements. Click any segment to explore use cases and compliance detail.

Hospitals & Health Systems
Clinical decision support, care coordination, and recall response across integrated delivery networks.
View use cases →
Retail & Specialty Pharmacies
Automated dispensing, recall notification, and patient safety workflow audit trails.
View use cases →
Pharmaceutical Manufacturers
FDA 21 CFR Part 11 compliant records for batch release, labeling, and recall management.
View use cases →
Distributors & Wholesalers
DSCSA-mandated recall response. $50K–$200K ACV. 6–9 month sales cycle. No discretionary budget needed — compliance is legally required.
View use cases →
Long-Term Care & Nursing
Medication management, incident reporting, and resident safety protocol AI accountability.
View use cases →
Compounding Pharmacies
AI decision chains for 503A & 503B compounding workflows and USP <800> compliance.
View use cases →
PBMs & Managed Care
Auditable prior authorization, formulary management, and utilization review AI records.
View use cases →
CROs & Clinical Trial Sites
21 CFR Part 11 audit trails for AI-assisted protocol deviation and adverse event reporting.
View use cases →
Government & Military Health
FedRAMP-aligned AI accountability for VA, DoD, and IHS federal health programs.
View use cases →
Contact MedNexLabs

Partner with the
compliance layer.

We are currently onboarding pilot partners and enterprise licensees across the healthcare and pharmaceutical supply chain. Technical documentation and architecture details are available under NDA.

Send a Message
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Sent directly to contact@mednexlabs.com · Response within 1 business day
Direct Contact
📧
Emailcontact@mednexlabs.com
⏱
Response TimeWithin 1 business day
🔒
IP StatusPatent Pending · Assigned to HealthNex IP Holdings LLC
Request Types
📋 Technical Briefing
Schedule a briefing to learn how VMARAS works for your environment.
🧪 Distributor Pilot
Structured 90-day pilot for pharmaceutical distributors under DSCSA mandate. $50K–$200K ACV. Proof chain included from day one.
💼 Platform Embed
API co-sell, embedded module, or white-label OEM licensing for health tech platforms. Architecture available under NDA.
📈 Investor Inquiry
Deck and financials available upon request.
🏗
MedNexLabs LLCAI Accountability Platform