What RxLogix Corporation does

RxLogix Corporation is a private pharmacovigilance (PV) and risk management software company founded in 2010, headquartered in Aventura, Florida, with 51-100 employees distributed across offices in the US (Princeton, Irvine), UK (Chadwell Heath), Germany (Lörrach), India (Noida, Bengaluru), and Japan (Tokyo). The company builds a cloud-native, AI-enabled SaaS platform that serves pharmaceutical manufacturers and global regulatory agencies — most notably the US FDA, where its FAERS II system has been live since 2021-11 processing 25M+ cases for 2,800+ users, and the European Medicines Agency, where its pan-European Substance Management System went live in 2025-12 covering 35M+ reports.

The core product is a modular PV platform covering the full safety lifecycle — case management, signal detection, aggregate and periodic reporting (PSUR/PBRER/IND/NDA), publishing, risk management, quality, gateways, data hub, clinical safety, and analytics — delivered as subscription SaaS on AWS with GxP, 21 CFR Part 11, ISO 27001, SOC 2 Type II, HIPAA, GDPR, and EU-U.S. Data Privacy Framework compliance. In 2026-04 the company launched PVOne.AI, a fourth-generation agentic AI layer that applies NLP, autonomous agents, anomaly detection, predictive analytics, and recommendation engines to automate case processing and decisioning. The company also sells Safety-in-a-Box, a bundled mid-market offering at a flat yearly fee, and extends into adjacent regulated verticals including vaccines, combination products, and medical devices.

Commercially, RxLogix operates a subscription-based enterprise SaaS model with multi-year contracts, professional services for implementation and validation, and managed services for ongoing safety operations. Named customers include the FDA, EMA, Moderna, Incyte, Organon, ProPharma, and Nobel Biocare, alongside other Top 20 pharma accounts; the company also works through PV BPO and implementation partners to extend reach. No external funding rounds are publicly disclosed, indicating growth has been funded by operating cash flow. Leadership is founder-led: Raj More serves as CEO and Chief Architect, Christopher M Lee as COO, Vishal Singh as VP of IT & Security / CISO, and Suranjan De as VP of Client Relations & Product Innovation.

Name

RxLogix Corporation

Legal name

RxLogix Corporation

Website

https://rxlogix.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

51–100 employees

Short description

RxLogix is a private pharmacovigilance SaaS company serving global regulators and pharma — its PV platform powers FDA's FAERS II and EMA's substance management system, with a new PVOne.AI agentic AI layer and bundled mid-market Safety-in-a-Box offering.

Ownership category

akta.pro rank

Product category

Pharmacovigilance Software

NAICS

Software Publishers (5132), Software Publishers (51321), Computing Infrastructure Providers, Data Processing, Web Hosting, and Related Services (518), Custom Computer Programming Services (541511)

SIC

Services-Prepackaged Software (7372), Services-Computer Programming, Data Processing, Etc. (7370)

akta.pro primary industry

PV Regulatory Submissions & Safety Reporting (E2B/CIOMS/Expedited) (HLAGALAJ)

akta.pro secondary industries

Pharmacovigilance Quality & Compliance (PV audits, QPPV support, PSMF) (HLAGAKAH), DTx/SaMD Evidence, Outcomes & Real-World Data (RWE) Platforms (HLACANAM), Cloud Compliance, Audit & Continuous Controls Monitoring (CCM/GRC) (HDABAHAI)

Keywords

• Pharmacovigilance software
• Drug safety platform
• Adverse event management
• Signal detection software
• Regulatory reporting SaaS

Headquarters

HQ city

Irvine

HQ country

United States

HQ region

North America

Offices8 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations

Revenue model

1. SaaS Platform Licensing: Subscription-based SaaS licensing of the PV platform and individual modules (PV Case Management, PV Signal, PV Reports, PV Publisher, PV Central, PV Quality, PV Risk Manager). Multi-tenant cloud architecture with annual or multi-year contract terms.
2. Professional Services: Implementation services including Rapid PV Systems Implementation, PV Strategy with AI, Analytics and Reporting Services, Education and Training, and Global PV BPO services.
3. Managed Services: Ongoing managed services and operational support including cloud hosting, 24/7 support desk, inspection support, and continuous compliance monitoring.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

RxLogix builds and sells a unified, cloud-native pharmacovigilance (PV) SaaS AI Platform and related individual modules (PV Case Management, PV Signal, PV Reports, PV Publisher, PV Risk Manager, PV Central, PV Quality) for case intake and processing, signal detection, regulatory reporting, and compliance monitoring across the drug-safety lifecycle. Revenue is generated through subscription licensing of the platform and modules, complemented by professional services (Rapid PV Systems Implementation, PV Strategy, Analytics, Education, Global PV BPO) and managed services for cloud hosting, support, and inspection readiness.

Product overview

RxLogix offers a unified PV SaaS AI Platform architecture comprising integrated modules for the complete pharmacovigilance lifecycle. The core products include PV Case Management for intake and case processing (achieving 60-80% efficiency gains), PV Signal for signal detection and management (2-3x faster detection), PV Reports for regulatory and ad-hoc reporting, PV Publisher for document authoring (50%+ timeline reduction), and PV Risk Manager for risk oversight. Additional modules include PV Central (compliance monitoring), PV Quality (quality tracking), PV Gateway (automated submissions), PV DataHub (data integration), PV Clinical (clinical trial PV), and PV Analytics (predictive insights). Safety-In-A-Box packages the core platform capabilities into a simplified, faster-to-implement solution. All products share a single governed data model, automated application layer, and unified AI capabilities powered by domain-trained models including the fourth-generation PVOne.AI agentic AI.

Differentiator

Problem solved

Functional benefit

Brands

• Safety-In-A-Box: Cloud-native, AI-powered pharmacovigilance platform that unifies the full PV lifecycle into a single scalable ecosystem
• PVOne.AI
• RxLogix Agentic AI

Products and services

• PV SaaS AI Platform Unified cloud-native pharmacovigilance platform powered by AI that covers the full safety lifecycle (case intake through regulatory submission) with a single governed data model, automated application layer, and one source of truth for all PV operations.
• Safety-In-A-Box Complete end-to-end PV solution that consolidates the full pharmacovigilance lifecycle into a single, scalable ecosystem with 50-70% faster implementation timelines, 30-50% lower infrastructure costs, and 99.9%+ platform availability for mid-market and emerging pharma/biotech.
• PV Case Management AI-powered adverse event processing and case intake solution that automates global case intake, follow-up, triage, processing, and reporting with medical coding against MedDRA and WHO-DD standards.
• PV Reports Self-service regulatory reporting and analytics tool supporting canned and ad-hoc reports with out-of-the-box visualizations, automated report generation, and integrated Spotfire analytics.
• PV Signal Signal detection and management platform providing dynamic data mining and Bayesian analytics for detecting signals, uncovering patterns, and recognizing emerging trends in adverse event report data; detects signals 2-3x faster with 40-60% fewer false positives.
• PV Publisher Global regulatory submission and document authoring solution that automates content creation for PBRERs, DSURs, PSMFs, and PV Agreements with AI-assisted automation from plan to publish.
• PV Risk Manager Risk identification and management solution integrated into the unified PV platform for detecting and investigating emerging safety signals with risk oversight capabilities.
• PV Central Compliance monitoring and data harmonization solution that unifies PV business operations, enables intelligent workflows, and delivers real-time actionable insights for compliance oversight.
• PV Quality Quality monitoring solution for global regulatory compliance with embedded quality checks, CAPA tracking, and issue resolution capabilities for inspection readiness.
• PVOne.AI Fourth-generation agentic AI solution providing intelligent orchestration across end-to-end safety operations; domain-trained models deliver up to 80% reduction in manual effort, 75% higher reviewer productivity, and up to 50% touchless workflows with human-in-the-loop controls.
• Rapid PV Systems Implementation Implementation service to rapidly stand up the RxLogix PV platform for enterprise and mid-market customers, supporting faster timelines versus legacy deployments.
• Managed Services and Operational Support Ongoing managed services and operational support including cloud hosting, 24/7 support desk, inspection support, and continuous compliance monitoring for customers running the PV platform.

Quantifiable outcome

• 60-80% fewer manual touchpoints in case processing
• +8 more outcomes

Named customers10 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration11 records

AI capability9 records

Feature8 records

Partnerships

Six partnerships are on record, tiered core and minor.

• European Medicines Agency (EMA)coreStrategic or Co-development Partner · 29 November 2023Strategic software agreement with EMA to develop the new Signal and Safety Analytics (SSA) platform including RxLogix PV Signal, PV Reports, and PV Analytics. The platform supports signal detection and validation activities for the European Medicines Regulatory Network (EMRN) across 35M+ safety reports.
• Booz Allen HamiltoncoreImplementation/ SI/ Consulting Partner · 19 November 2018Booz Allen Hamilton supported the implementation of RxLogix PV Signal and PV Reports at the U.S. FDA as part of the FAERS modernization effort. This was a critical implementation partnership for the landmark FDA contract.
• AWS (Amazon Web Services)coreTechnology or IntegrationCloud infrastructure provider for RxLogix's multi-tenant SaaS platform. AWS-based hosting provides scalability, reliability, and performance for enterprise PV deployments.
• EisaiminorStrategic or Co-development PartnerGuest speaker collaboration at RxLogix PV Digital Transformation Seminar Series 2024-Tokyo. E. Stewart Geary, MD, Global Safety Officer at Eisai presented on CIOMS XII Structured Benefit Risk Framework.
• Astellas PharmaminorStrategic or Co-development PartnerGuest speaker collaboration at RxLogix PV Digital Transformation Seminar Series 2024-Tokyo. Ken Kubota, SVP PV Operations at Astellas participated as industry speaker.
• LundbeckminorStrategic or Co-development PartnerGuest speaker collaboration at RxLogix PV Digital Transformation Seminar Series 2024-Tokyo. Jens Nordahl, Senior Project Manager at Lundbeck participated as industry speaker.

Scale indicators15 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Parexel International: Parexel is a global CRO with significant pharmacovigilance service offerings. As a CRO-led PV service provider, it competes with RxLogix's PV BPO partners and managed services for outsourced safety operations at large pharma and biotech.
• IQVIA: IQVIA offers safety/pharmacovigilance technology alongside its dominant CRO services and real-world evidence platforms. RxLogix is named alongside IQVIA as a leading vendor in ResearchAndMarkets.com PV market reports, and IQVIA represents a broad incumbent that competes for both PV software and PV BPO spend.
• Cognizant Life Sciences (PV Services): Cognizant provides pharmacovigilance BPO and technology services at scale to large pharma. It competes with RxLogix's Global PV BPO partner channel and full PV platform stack, particularly for outsourced case processing and signal management.

Emerging players

• AB Cube: AB Cube specializes in E2B safety reporting and pharmacovigilance data exchange tools. It competes with RxLogix's PV Gateway and E2B/ICSR submission capabilities, often as a complementary tool or alternative for safety reporting workflows.
• EXTEDO: EXTEDO provides regulatory information management and pharmacovigilance/safety reporting software. It overlaps with RxLogix in regulatory submission and safety reporting modules, particularly for European mid-market customers.
• Ennov: Ennov offers a unified regulatory, quality, and pharmacovigilance platform targeted at mid-market life sciences companies. It competes with RxLogix in safety case management and regulatory reporting for smaller and mid-sized pharma and biotech.

Direct peers

• Sarjen Systems: Sarjen Systems provides pharmacovigilance software including case processing and reporting solutions to mid-size pharma. It competes with RxLogix for mid-market PV deals, particularly against Safety-in-a-Box.
• ArisGlobal: ArisGlobal's LifeSphere Safety and MVPS platforms are among the most direct competitors to RxLogix's PV platform, covering case intake, signal management, and regulatory reporting. RxLogix explicitly supports interoperability and migration from ArisGlobal, and both vendors target top-20 pharma and mid-market PV modernization.
• Veeva Systems: Veeva Vault Safety is a cloud-native pharmacovigilance application within Veeva's broader life sciences commercial/clinical cloud. Veeva is a direct PV platform peer and a broader life sciences CRM/regulatory incumbent that competes with RxLogix for IT budget allocation in top pharma.
• Oracle (Argus Safety): Oracle Argus Safety is the incumbent market leader in pharmacovigilance safety databases used by most large pharma. RxLogix's PV Case Management, PV Signal, and PV Reports modules directly compete against Argus Safety's case processing, signal detection, and reporting capabilities, and RxLogix's platform explicitly supports migration from Argus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/rxlogix
• Facebookfacebook.com/rxlogix
• LinkedInlinkedin.com/company/rxlogix-corporation

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Subsidiaries3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about RxLogix Corporation