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Adverse Event Reporting & Medical Information
Post Marketing – Pharmacovigilance
MICC (Medical information contact center)
Global and local literature monitoring
Case Management
Periodic safety reports
Signal Management
Risk Management Plan
Global submissions
Regulatory intelligence
Clinical Pharmacovigilance
Drugs: Nonprescription (OTC)
24/7 Medical Call Center
Medical Device Vigilance
Device Vigilance Report preparation and submission
Adverse Device Effect (ADE)/ Medical Device Incident (MDI) trending and evaluation
Vigilance Quality Assurance including SOP development
ADE and MDI reconciliation
Strategic Regulatory Services
Structured product labelling service
Preparation and submission of final dossier preparation, compilation and filling (ANDAs, NDAs)
Efficiency response management
Veterinary Pharmacovigilance
Scientific Writing Services
Toxicology reports
Health Hazard assessment /evaluations
Clinical and non-clinical summaries
Genotoxicology reports
Quality Compliance
Document management
Learning management
Quality management
Database Hosting Services
QPPV and LPPV Services
xEVMPD & Product Management System services
PSMF Maintenance
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