HAROM India
Why HAROM

One partner for smarter, controlled drug safety.

Pharmaceutical companies, MAHs and CROs choose HAROM India for compliance-first pharmacovigilance — technology-assisted, human-reviewed, and delivered under one accountable model.

Compliance-first. Expert-led. Connected.

Partnering with HAROM India
What sets us apart

The reasons teams choose HAROM

Outcomes, not buzzwords — here's what partnering with HAROM actually delivers.

Compliance-first & audit-ready

Purpose-built for GVP and 21 CFR Part 11, with automatic, tamper-evident audit trails — inspection-ready by design.

AI-assisted, human-reviewed

AI and automation do the heavy lifting; qualified PV professionals review and approve every safety-critical decision.

Software + services under one roof

The platform, the products and the expert team — one partner for your whole pharmacovigilance programme.

Global regulatory coverage

Support for the world's major regulators — EMA, FDA, MHRA, Health Canada, CDSCO, WHO and more.

Cost-effective for MAHs & CROs

AI-assisted delivery keeps quality high and cost down, for organisations of every size.

India-based expert team

Seasoned pharmacovigilance professionals delivering expert drug safety support, globally.

AI · Automation · Human-in-the-loop

Fast where it should be. Human where it matters.

AI and automation remove the repetitive work; qualified experts stay in control of every safety-critical decision; and the system records everything automatically.

1

Automation does the heavy lifting

Automation and AI handle the repetitive work — validations, checks, coding assistance and first-pass drafting.

2

Expert reviews & approves

Qualified PV professionals review and approve every safety-critical decision. Nothing reaches a regulator without human sign-off.

3

System records

A complete, tamper-evident audit trail captures who did what and when — traceable and inspection-ready.

4

Compliance preserved

Designed to support ICH, GVP and 21 CFR Part 11 controls — by design.

Outcomes

Results that matter to your PV operations

Lower operating cost

AI and automation take on the repetitive work behind every case, so expert time goes where it counts.

Inspection-ready

A complete, tamper-evident audit trail on every action — traceable and ready for regulators.

Faster turnaround

Cases move from intake to submission with less manual effort and less delay.

Let's talk pharmacovigilance

Let's shape your PV programme together

Partner with HAROM India for smart, compliant drug safety. Book a demo or talk to our experts.

Inspection
Ready
GovernanceControlled SystemsInspection-ReadyTrained Teams