iSAFETY

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

Our Delivery Statistics

5,00,000

Case Management

3,00,000

Medical Reviews

10,000

Aggregate Reports

30,00,000

Literature Analysis

8,000

Signal Reports

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

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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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