Archives: Service

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

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

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

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

Periodic and Ongoing Literature Search and Analysis for all product categories

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

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

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

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