Global Pharmacovigilance Services and Strategic Solutions

Compliant, Scalable and Efficient Solutions for all your Pharmacovigilance and Product Safety needs

At iSafety, we focus on Customized Solutions to meet your business objectives.
We bring in best industry practices to provide you with Compliant and Cost Optimized Solutions for a Single Safety Process or End to End Pharmacovigilance Services.

Case Processing & Regulatory Reporting

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

Periodic Aggregate Reports

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

Signal Detection & Analysis

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

EU EudraVigilance Case Management

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

Literature Search & Analysis

Periodic and Ongoing Literature Search and Analysis for all product categories

Risk Management

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

Medical Information Center

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

Global Labeling and Company Core Data Sheets (CCDS)

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

Oracle ARGUS Safety Database Solutions

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

Request for Information and speak with our Pharmacovigilance experts for tailor-made solutions!

Submit an RFI/RFP

iSAFETY SERVICE SOLUTIONS

Contact Us

Business Query
sales@isafetysystems.com
Call iSAFETY
+1 973 705 7399

iSAFETY WORLDWIDE

USA – 103, Carnegie Center Dr., Princeton, NJ 08540

UK – Stockley Park, The Square, Hayes, Uxbridge UB11 1FW

GERMANY – Potsdamer Platz 1, 10785, Berlin

INDIA – Sri Ram Towers, Somajiguda, Hyderabad, 500082

JAPAN – Shiodome Building, 1-2-20 Kaigan, Minato-Ku, Tokyo 105-0022