Achieve your business goals

At iSafety, we start by listening carefully and understanding your requirements.

business goals

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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