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