iSAFETY combines extensive Product Safety industry experience and multi-country Regulatory systems expertise Marketing Authorization Holders (MAH) today recognize the need for a comprehensive Product Safety, Surveillance
to deliver quality and innovation driven solutions and services for businesses.
and Reporting System solution that addresses challenges of handling complex safety and compliance processes
during concept-to-market phases including those associated with:
iSAFETY’s end-to-end Safety and Regulatory solutions and services focus on multiple areas including:
AS A PHARMACOVIGILANCE SERVICE PROVIDER, WE OFFER
Case intake, Triage, Adverse Event processing, Quality Review, Medical Review and Regulatory Submissions
Read MoreDrafting of Periodic Aggregate Reports, Medical Review of PBRERs, PADERs, ACOs, PSURs
Read MoreSignal Detection Reports Drafting and Medical Reviews, PRAC Changes, HA Updates, Risk-Benefit Analysis
Read MoreEVDMS case Download, Screening, Triage, Case Processing for L2A & MLM, Medical Review and Reporting
Read MorePeriodic and Ongoing Literature Search and Analysis for all product categories
Read MoreEU Risk Management Plans (RMP) and US REMS Preparation by Pharmacovigilance Physicians
Read MoreMedical Information Call Center Services, Adverse Events and Quality Complaints handling
Read MoreSmPC/Label/PL Creation and Updates, Brand Comparisons, Gap Analysis, Label Artwork and Scientific Translations
Read MoreCost Effective Safety Database Services with ICH E2B(R3) Compliant System
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