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Salvus

An automated end-to-end Drug Safety Database, guarantees compliance and promotes alignment among global teams. A validated, GxP-ready and CFR-11 compliant solution.

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SALVUS COMPLAINT TO 10+ PHARMACEUTICAL REGULATORY AGENCIES
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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

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Medical Review

Salvus facilitates medical review processes by allowing medical experts to assess and evaluate individual cases 

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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 

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Workflow Automation

Salvus automates various tasks and workflows, streamlining case processing, follow-up, and reporting.

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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 

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Signal Management

Advanced algorithms and statistical methods are employed to detect and evaluate safety signals

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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.

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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

Businessman

Emzor Pharmaceutics

See why business teams choose Salvus

Experience the everyday excellence of a unified, AI-powered solution to all your business needs

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