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Ask Anything. Know Everything.
Across Every Quality System. 

RxHorizon brings an AI intelligence layer to your LIMS, MES, QMS, DMS, and every quality data source — so your team can interact with data in plain English, get instant answers, and generate audit-ready reports without switching a single system.

21 CFR Part 11 Compliant

No Workflow Disruption 

Built-in Audit Trail

The Data Already Exists Inside Your Systems. RxHorizon Brings It Together.

Pharma and life sciences companies sit on extraordinary volumes of carefully captured data — across manufacturing systems, quality systems, clinical trials, and regulatory documents. But when your teams need to use it, that data lives in silos: LIMS, MES, QMS, DMS, ERP, SAS, OneDrive, FTP servers, and a dozen formats in between.

RxHorizon is the agentic intelligence layer that sits on top of everything you already use. Three capabilities, one architecture, built to the standard pharma is held to.

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An AI intelligence layer on top of the systems you already use

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Connect your Different Systems

LIMS, MES, QMS, DMS, ERP, and more — your quality data is spread across disconnected systems that don't talk to each other. 

AI Intelligence Layer on your existing systems

RxHorizon creates a unified data warehouse with an AI intelligence layer on top — connecting every source without disrupting your existing workflows. 

Chat in Natural Language, Get Full Visibility

Your quality team interacts with all their data through natural language, no waiting. Ask a question, get an answer — across every connected system. 

Generate Audit Ready Quality Reports

Auto-generate regulatory-compliant quality and audit reports with full statistical analysis, graphs, interpretations, and complete audit trails. 

Three Capabilities. One Shared Data Foundation.

For Quality Manufacturing

RxPQR

An agentic system that auto-populates APQRs end-to-end — pulling data, running Cpk and Ppk analysis, generating charts, and drafting interpretations.

For Quality Data Intelligence

RxGaze

Ask your manufacturing and quality data anything, in plain English. Get instant answers across every connected system — with full traceability.

For Clinical Study Reports

RxCSR

An agentic CSR engine that drafts submission-ready, ICH E3-compliant reports from your protocols, SAPs, and TLFs with human in the loop design

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Cross-System Intelligence For Pharma and Life Sciences

Your data, your evidence, your reports — already exist. RxHorizon makes them usable. Ask anything in plain English. Generate audit-ready APQRs and CSRs in a fraction of the time. All without changing a single workflow.

21 CFR Part 11 Compliant. ICH E3 · FDA-EMA AI Principles

Built-in Audit Trail

An AI intelligence layer on top of the systems you already use

Every RxHorizon capability - RxPQR, RxGaze, and RxCSR are all built on the same foundational architecture — a unified data layer connecting your systems, with an AI intelligence layer on top.

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RxPQR

APQRs In Hours, Not Weeks.

From weeks of manual reporting to APQRs your team can review the same day.

Generating a single APQR used to mean weeks of pulling data from LIMS, MES, QMS, DMS — then formatting, reconciling, running statistics, and drafting interpretations by hand. RxPQR's agents do all of it for you, end-to-end.

Three clicks to start. Select product, dosage, and review period. The agents take over from there.

  • Auto-populate every section from the unified data warehouse — no manual extraction.

  • Run statistical analysis — Cpk, Ppk, trend analysis — across every process parameter.

  • Generate the charts your reviewers expect, automatically.

  • Draft interpretations explaining what the numbers actually mean.

  • Complete audit trails on every calculation, with human-in-the-loop sign-off.

RxGaze

Instant Answer to Queries.

From days of system-hopping to instant cross-system answers of natural language queries.

When a question comes up — "show me all OOS events for Product X across the last 12 months" — your team shouldn't have to log into five systems and wait three days for an answer.

 

RxGaze sits on top of every connected source and answers in seconds, in plain English.

  • Cross-system natural language queries — LIMS, MES, QMS, DMS, ERP, all in one prompt.

  • Source citations on every answer — exact table, row, and column.

  • No SQL. No IT tickets. No waiting. Your analysts query their own data.

  • Every conversation saved and searchable — institutional memory captured.

  • Role-based access controls built into every interaction.

RxCSR

Clinical Study Reports In Days.

From 8–12 weeks of manual drafting to 2–3 weeks of focused review.

A Clinical Study Report is the document that goes to the FDA, the EMA, and the world — but drafting it has historically meant medical writers spending months transcribing data from protocols, SAPs, and TLFs by hand.

 

RxCSR's agents draft the structured sections, ground every claim in source, and hand your medical writers back the work only they can do: scientific interpretation.

  • ICH E3-compliant structure across all 16 sections; TransCelerate CPT format also supported.

  • Built in alignment with FDA-EMA Joint Guiding Principles for Good AI Practice.

  • Parallel multi-agent engine drafts multiple sections concurrently.

  • 100% source grounding — every claim hyperlinked to its protocol, SAP, or TLF citation.

What Changes with RxHorizon

80%

Reduction in APQR generation time  

10x

Faster cross-system data retrieval

98%

Reduction in initial CSR draft turnaround

100% 

Audit trail coverage across every interaction 

Built For Pharma and Life Sciences. From Day One.

Compliance isn't an add-on. Every layer of RxHorizon — from the data warehouse to the AI engine to the reports it generates — is engineered to meet pharmaceutical regulatory standards.

Your data never leaves your environment. Ever.

Your systems. Your servers. Your control.

21 CFR Part 11 Compliant

Audit trails, e-signatures, role-based access controls.

ICH E3 Compliant

Section-level structure for clinical study reports.

FDA-EMA AI Principles

Built for Good AI Practice in regulated settings.

Human-in-the Loop

Your experts retain final review and sign-off authority.

Bring Cross-System Intelligence To Your Pharma And Life Sciences Workflows

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