We’re pleased to announce that iSafety Systems has joined ProPharma Group.

Together we are forming the world’s leading provider of pharmacovigilance services for clients seeking strategic solutions and comprehensive drug safety support from clinical through post-approval. Learn about our expanded services.


iSAFETY combines extensive Product Safety industry experience and multi-country Regulatory systems expertise
to deliver quality and innovation driven solutions and services for businesses.

Marketing Authorization Holders (MAH) today recognize the need for a comprehensive Product Safety, Surveillance
and Reporting System solution that addresses challenges of handling complex safety and compliance processes
during concept-to-market phases including those associated with:

  • Quality Processes

  • Scalable Safety Profiles

  • Safety Data Integrity

  • Signal Management

  • Risk Management

  • Regulatory Compliance

Focus Areas

iSAFETY’s end-to-end Safety and Regulatory solutions and services focus on multiple areas including:

  • Pharmacovigilance

  • Strategy Consulting

  • Safety Technology

  • Medical Information

  • Operations Outsourcing

  • Literature Surveillance


Global Pharmacovigilance Services and Strategic Solutions


Case Processing & Regulatory Reporting

Case intake, Triage, Adverse Event processing, Quality Review, Medical Review and Regulatory Submissions

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Periodic Aggregate Reports

Drafting of Periodic Aggregate Reports, Medical Review of PBRERs, PADERs, ACOs, PSURs

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Signal Detection & Analysis

Signal Detection Reports Drafting and Medical Reviews, PRAC Changes, HA Updates, Risk-Benefit Analysis

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EU EudraVigilance Case Management

EVDMS case Download, Screening, Triage, Case Processing for L2A & MLM, Medical Review and Reporting

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Literature Search & Analysis

Periodic and Ongoing Literature Search and Analysis for all product categories

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Risk Management

EU Risk Management Plans (RMP) and US REMS Preparation by Pharmacovigilance Physicians

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Medical Information Center

Medical Information Call Center Services, Adverse Events and Quality Complaints handling

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Global Labeling and Company Core Data Sheets (CCDS)

SmPC/Label/PL Creation and Updates, Brand Comparisons, Gap Analysis, Label Artwork and Scientific Translations

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Oracle ARGUS Safety Database Solutions

Cost Effective Safety Database Services with ICH E2B(R3) Compliant System

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