PV Gateway

PV Gateway is a cloud-based regulatory submission exchange platform developed by RxLogix. It is designed to support electronic regulatory submissions, including Individual Case Safety Reports (ICSRs) and Periodic Reports, and functions as an alternative to traditional EDI/B2B gateway solutions such as Axway. The platform provides a centralized mechanism to configure, manage, and monitor regulatory data exchanges between trading partners and regulatory authorities using industry-standard protocols.

PV Gateway is intended for pharmacovigilance and drug safety teams that need a compliant, cost-effective gateway for submitting regulatory data across the complete drug lifecycle. It operates as an ESTRI Gateway cloud service and supports AS2 and AS3 exchange protocols.

Key Features and Capabilities

• AS2/AS3 Exchange: Supports configuration and exchange of information using AS2 and AS3 protocols between trading partners and regulatory authorities, enabling submission of ICSRs, Periodic Reports, and other regulatory submissions.
• Automated Partnership Setup: Includes built-in capability to generate and exchange digital signatures between two trading partners directly within PV Gateway, reducing manual setup steps.
• Alerts and Notifications: Allows users to set thresholds and receive alerts for delayed submissions, pending Message Disposition Notifications (MDNs), expiring certificates, and other business-critical events.
• GDPR Compliance: Supports storing payloads in the user's own cloud repository, with controlled access granted to PV Gateway for data processing, helping organisations meet data privacy requirements.
• SSO Support: Can be integrated with SAML-based Single Sign-On (SSO) identity providers.
• Integration with PV Suite: Integrates with RxLogix's broader PV Suite of pharmacovigilance applications.
• Third-Party System Integration: Provides a client agent to facilitate integration with multiple disparate systems, funnelling information through a common gateway. APIs are available for connecting to enterprise systems and automating workflows.

Submission Types Supported

• Individual Case Safety Reports (ICSRs)
• Periodic Reports
• Other regulatory submissions across the complete drug lifecycle

Deployment and Integration

• Delivered as a cloud service, enabling configuration and exchange setup in a short timeframe.
• Integrates with the RxLogix PV Suite, including products such as PV Case Management, PV Reports, PV Publisher, PV Signal, PV Risk Manager, and others.
• Supports integration with enterprise systems via APIs and a secure client agent for connecting disparate third-party systems.
• Compatible with SAML-based SSO identity providers for access management.

PV Gateway is positioned as a single platform for regulatory exchange, combining protocol support, automated certificate and signature management, compliance controls, and system monitoring within a cloud-hosted service.