Submit an RFI/RFP

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.

icon

Case Processing & Regulatory Reporting

Case Processing & Regulatory Reporting

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

Periodic Aggregate Reports

Periodic Aggregate Reports

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

Signal Detection & Analysis

Signal Detection & Analysis

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

EU EudraVigilance Case Management

EU EudraVigilance Case Management

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

Literature Search & Analysis

Literature Search & Analysis

Periodic and Ongoing Literature Search and Analysis for all product categories
icon

Risk Management

Risk Management

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

Medical Information Center

Medical Information Center

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

Global Labeling and Company Core Data Sheets (CCDS)

Global Labeling and Company Core Data Sheets (CCDS)

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

Oracle ARGUS Safety Database Solutions

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

About Us

iSafety, is a leading Scientific Process Outsourcing (SPO) organization, uniquely focused on delivering Compliant and Quality Scientific Services for Global Product Safety, Risk Management and Technology requirements of Biopharmaceutical, Medical Device, Cosmetic and Consumer Product companies

Contact Us

6-3-552, Sri Ram Towers, Erra Manzil, Hyderabad, 500082, India

Email: info@isafetysystems.com
Phone: +1 609 759 9190

Services

Fast Links

iSafety 2019 © All Rights Reserved.