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Cross-System Intelligence For Pharma and Life Sciences

Your data, your evidence, your reports — already exist. RxHorizon makes them usable without changing a single workflow.

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

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

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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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

RxPQR

APQRs In Hours, Not Weeks.

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

An agentic system that auto-generates your Annual Product Quality Reviews end-to-end. Select product, dosage, and review period — the agents do the rest.

  • Auto-populates every section from your unified data warehouse

  • Runs Cpk, Ppk, and trend analysis with auto-generated charts

  • Drafts interpretations with full audit trails — ready for your sign-off

RxGaze

Instant Answer to Queries.

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

Query LIMS, MES, QMS, DMS, and ERP in plain English. No SQL. No IT tickets. No system-hopping.

  • Cross-system natural-language queries across every connected source

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

  • Every question saved and searchable — institutional memory captured

RxCSR

Clinical Study Reports In Days.

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

An agentic engine that drafts submission-ready, ICH E3-compliant CSRs from your protocols, SAPs, and TLFs.

  • Parallel multi-agent drafting across all 16 ICH E3 sections

  • 100% source-grounded — every claim cited to its protocol, SAP, or TLF

  • Feedback-aware regeneration — refine any section without disturbing the rest

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.

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 

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

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