SALVUS COMPLAINT TO 10+ PHARMACEUTICAL REGULATORY AGENCIES
Achieve more with less
Salvus is a unified, intelligently automated, end-to-end platform that helps safety
teams save time, achieve, scalable compliance, and make better decisions.
Adverse Event Reporting
Salvus allows the collection and recording of adverse event data related to drug usage
Regulatory Compliance
Salvus ensures compliance with pharmacovigilance regulations and guidelines, providing necessary reports
Medical Review
Salvus facilitates medical review processes by allowing medical experts to assess and evaluate individual cases
Data Import and Integration
It provides automated mechanisms to import data from diverse sources, including electronic health records (EHRs)
Case Management
It enables the tracking and management of individual cases, including data entry, review, and follow-up
Data Analysis and Reporting
Salvus offers advanced analytical tools to explore and analyze safety data, generating comprehensive reports
Workflow Automation
Salvus automates various tasks and workflows, streamlining case processing, follow-up, and reporting.
Coding and Standardization
Salvus automates coding of adverse events and medications using standard terminologies like MedDRA
Signal Detection
In-built statistical algorithms help in identifying potential safety signals from the reported adverse events.
Risk Management
It supports the implementation of risk minimization strategies, such as Risk Evaluation and Mitigation Strategies
Signal Management
Advanced algorithms and statistical methods are employed to detect and evaluate safety signals
Signal Triage
Automation tools help prioritize and triage safety signals based on predefined criteria, ensuring efficient allocation of resources
INTEGRATED PLATFORM
A platform for guaranteed compliance
With ICH, EMA, FDA, EU GMP Annex 11, US FDA 21 CFR part 11, and EMA’s Good Pharmacovigilance Practice (GVP) guidelines, Salvus is compliant with many regulations and directives from around the world.
We love our customers. Happily, the feeling is mutual.
Salvus has been a game-changer for our pharmacovigilance operations. Its GxP-ready and CFR-11 compliant features have ensured our compliance with industry regulations. The automated intake and E2B R2/R3 XML Import and Export support have significantly streamlined our data handling processes, saving time and improving efficiency.
Stanley Joel
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Senior VP, Emzor Pharmaceuticals
