iSAFETY
iSAFETY combines extensive Product Safety industry experience and multi-country Regulatory systems expertise Marketing Authorization Holders (MAH) today recognize the need for a comprehensive Product Safety, Surveillance
to deliver quality and innovation driven solutions and services for businesses.
and Reporting System solution that addresses challenges of handling complex safety and compliance processes
during concept-to-market phases including those associated with:
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Quality Processes
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Scalable Safety Profiles
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Safety Data Integrity
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Signal Management
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Risk Management
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Regulatory Compliance
Focus Areas
iSAFETY’s end-to-end Safety and Regulatory solutions and services focus on multiple areas including:
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Pharmacovigilance
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Strategy Consulting
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Safety Technology
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Medical Information
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Operations Outsourcing
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Literature Surveillance
AS A PHARMACOVIGILANCE SERVICE PROVIDER, WE OFFER
Global Pharmacovigilance Services and Strategic Solutions
Case Processing & Regulatory Reporting
Case intake, Triage, Adverse Event processing, Quality Review, Medical Review and Regulatory Submissions
Read MorePeriodic Aggregate Reports
Drafting of Periodic Aggregate Reports, Medical Review of PBRERs, PADERs, ACOs, PSURs
Read MoreSignal Detection & Analysis
Signal Detection Reports Drafting and Medical Reviews, PRAC Changes, HA Updates, Risk-Benefit Analysis
Read MoreEU EudraVigilance Case Management
EVDMS case Download, Screening, Triage, Case Processing for L2A & MLM, Medical Review and Reporting
Read MoreLiterature Search & Analysis
Periodic and Ongoing Literature Search and Analysis for all product categories
Read MoreRisk Management
EU Risk Management Plans (RMP) and US REMS Preparation by Pharmacovigilance Physicians
Read MoreMedical Information Center
Medical Information Call Center Services, Adverse Events and Quality Complaints handling
Read MoreGlobal Labeling and Company Core Data Sheets (CCDS)
SmPC/Label/PL Creation and Updates, Brand Comparisons, Gap Analysis, Label Artwork and Scientific Translations
Read MoreOracle ARGUS Safety Database Solutions
Cost Effective Safety Database Services with ICH E2B(R3) Compliant System
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