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Regulatory & Safety Documentation
Showing 98 results
Progressive GRRACE logo
Progressive GRRACE

by Nextrove

Automated reporting rules design, testing, and deployment for Argus Safety with audit trail and compliance tracking.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Progressive ClinConnect logo
Progressive ClinConnect

by Nextrove

Bulk case data import and automated coding for Argus Safety with fast case creation and compliance-ready validation.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Progressive MICC logo
Progressive MICC

by Nextrove

Integrated contact center management for pharmaceutical adverse events, complaints, and medical inquiries with built-in telephony and case management.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Progressive Reporting & Analytics logo
Progressive Reporting & Analytics

by Nextrove

Drug safety data analysis, reporting, and interactive dashboards for pharmacovigilance decision-making.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Progressive TransX logo
Progressive TransX

by Nextrove

Multilingual translation for regulatory data, safety applications, and business communications across 35+ languages.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
VigiFlow logo
VigiFlow

by Uppsala Monitoring Centre

Consolidate adverse event reports from multiple reporters into a unified national database via web and mobile data entry applications.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
VigiLyze logo
VigiLyze

by Uppsala Monitoring Centre

Signal detection and management for medicines and vaccines, enriching national safety data with global insights from VigiBase.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
VigiMobile logo
VigiMobile

by Uppsala Monitoring Centre

Customizable mobile forms for structured adverse event and vaccine safety reporting by healthcare workers and the public, with offline capability.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
VigiFlow eReporting for Industry logo
VigiFlow eReporting for Industry

by Uppsala Monitoring Centre

ICH E2B-compliant safety report collection from manufacturers, with built-in WHODrug and MedDRA coding.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
VigiBase Search Services logo
VigiBase Search Services

by Uppsala Monitoring Centre

Access to WHO's global adverse event database for medicines and vaccines, covering 99% of the world's population.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
Safety-In-A-Box logo
Safety-In-A-Box

by RxLogix

End-to-end pharmacovigilance with AI-driven automation, real-time compliance monitoring, and rapid deployment for global safety operations.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
PV Signal logo
PV Signal

by RxLogix

AI-powered signal detection and lifecycle management for pharmacovigilance, with NLP analytics and unified workflows for faster risk identification and compliance.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
PV Publisher logo
PV Publisher

by RxLogix

Automated publishing of regulatory documents like PBRERs, DSURs, and PSMFs, reducing authoring time by 60-70% and timelines by over 50%.

Regulatory & Safety Documentation
AI Regulatory & Medical Writing
PV Risk Manager logo
PV Risk Manager

by RxLogix

Centralized Risk Management Plan authoring, workflow automation, and compliance oversight for drug safety and pharmacovigilance teams.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
PV Central logo
PV Central

by RxLogix

Real-time compliance tracking and SLA monitoring for pharmacovigilance teams across global regulatory frameworks.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
PV Quality logo
PV Quality

by RxLogix

AI-powered quality issue detection and CAPA tracking for pharmacovigilance compliance and audit readiness.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
PV Gateway logo
PV Gateway

by RxLogix

Secure regulatory submission exchange for ICSRs and periodic reports using AS2/AS3 protocols with automated digital signatures and real-time alerts.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety
PV DataHub logo
PV DataHub

by RxLogix

Centralized pharmacovigilance data warehouse with E2B(R3) compliance, native ETL for leading safety systems, and integrated access to public regulatory databases.

Regulatory & Safety Documentation
Pharmacovigilance & Drug Safety