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Pharmacovigilance System Implementation

End-to-end PV system setup services to help you stay compliant, audit-ready, and scalable from day one. We handle everything from system selection to go-live support.

Simplify Pharmacovigilance from Start to Go-Live

Implement fully compliant safety systems with expert-led planning, configuration, and validation.

Our Implementation Services

We provide a full range of services to help you plan, configure, validate, and support your PV system—all tailored to your organization's specific needs.
System Selection & Planning
We assess your needs and recommend the right system—like Argus, ARISg, or Veeva—and build a clear project plan with milestones to guide your implementation.
System Configuration
Custom workflows, user roles, data fields, and case routing logic—all set up according to your SOPs and compliance strategy.
Compliance Alignment
We ensure your system meets international standards like ICH E2B, FDA 21 CFR Part 11, EMA GVP modules, GxP, and GDPR.
Data Migration & Integration
Migrate your legacy safety data and connect your PV system with other tools like CTMS, EDC, and medical info platforms.
E2B Configuration & Gateway Setup
We enable automated ICSR submissions by configuring your system for secure gateway communication with health authorities.
Testing & Validation
We perform complete system validation (IQ/OQ/PQ) to ensure your PV platform works correctly and meets regulatory expectations.

Expert pharmacovigilance solutions to safeguard patients, ensure compliance, and drive innovation in drug safety. Partner with us for precision, vigilance, and regulatory excellence.

India

India - Headquarters
Pristine City Bakori Road, Wahgoli, Pune, Maharashtra - 412207
+91 90283 33221

India - Development Center
Baba Somnath Tower, Bypass Ramur Road, TP Nagar Haldwani Uttarakhand 263139
+91 90283 33221

Australia

Australia Office
ACN: 664 913 928
38 Energy Dr lyndhurst VIC 3975, Australia
+61 4 0461 3093