Ensuring Safety Database Compliance with Global PV Standards
Built for Compliance, Designed for Efficiency – The Future of PV Safety Databases
ICH E2B Compliance
Fully adheres to E2B (R2 & R3) standards for seamless regulatory submissions.
GVP & 21 CFR Part 11
Ensuring electronic records and signatures meet global validation requirements.
ISO GXP & GAMP-5 Certified
Developed in accordance with Good Pharmacovigilance Practices & global validation protocols.
End-to-End Audit Trail
Every system action is fully traceable, ensuring 100% compliance.
Centralized Safety Data
A unified platform for ICSR processing, aggregate reporting & risk detection.
Automated Compliance
AI-powered alerts ensure real-time regulatory tracking & case monitoring.
With HAROM India, your safety database is always audit-ready, fully compliant, and optimized for efficiency.
PV System Overview
Cost-OptimizedHAROM India's Approach – Cost-Effective PV Systems with Regulatory Excellence
Smarter Compliance, Lower Costs – AI-Driven, Globally Aligned PV Solutions
At HAROM India, we believe that Pharmacovigilance compliance should not be costly or complex. Our AI-powered PV systems are designed to be cost-effective, scalable, and aligned with global safety standards—helping clients reduce operational costs while maintaining full compliance.
End-to-End PV Services
From ICSR processing to aggregate reporting & risk detection, we ensure a seamless, fully compliant PV system.
Regulatory-Compliant AI Solutions
Automated case processing, compliance tracking & audit-ready documentation reduce manual effort & risks.
Affordable & Scalable Framework
Customizable solutions for small, mid-sized & large pharma/CROs, ensuring maximum efficiency at lower costs.
Expert-Led Compliance Audits
Helping organizations assess regulatory gaps & optimize PV workflows.
Whether you're a startup, a mid-sized pharma, or a global leader, HAROM India helps you build a fully compliant, cost-effective Pharmacovigilance system.
AI-Powered Compliance, Audit-Ready Systems & Seamless Global Regulatory Alignment
One Platform, Global Compliance – Expertise Across All Major Regulatory Authorities
Fully Compliant with Global Authorities
Our systems align with ICH, FDA, EMA, MHRA, CDSCO, WHO & other global regulatory requirements.
Audit-Ready Pharmacovigilance System
Our end-to-end PV services ensure transparency and risk mitigation across all safety processes.
AI-Driven Compliance Tracking
Our AI-driven safety database ensures clients meet global Pharmacovigilance regulations effortlessly.
Global Compliance Map
HAROM India's adherence to different regulatory bodies worldwide ensures your operations remain compliant across all markets.
Let’s Build a Smarter, AI-Driven PV System for You
Need a trusted PV partner? HAROM India offers AI-powered, compliant solutions—just fill out the form to get started.