Pharmacovigilance. Further together.
HAROM India is a pharmacovigilance company combining specialist PV services, quality-led processes and connected technology — so organisations can establish, run and evidence drug-safety operations with confidence.
People. Process. Technology.
HAROM India Private Limited
Mohali, Punjab, India
Establishment, services, technology. One partner.
We work with pharma and MAHs, emerging biotech, CROs and clinical sponsors, and PV and regulatory service providers — as a defined engagement, a complete workstream or an integrated PV operating model.
PV Establishment
Governance, QMS, trained roles and controlled technology — from requirement to inspection-ready operations.
PV Services
Safety operations, safety science and medical writing, PV quality and compliance — expert-led and delivered to a standard.
PV Technology
HAROM OnePV and the connected applications, under one login, with every action audited.
Sunil Verma
Founder & CEO
We are not just providing PV services — we are transforming pharmacovigilance into a smarter, simpler and inspection-ready system that is cost-effective and future-ready.
At HAROM India our purpose is clear: to advance pharmacovigilance through technology-assisted, expert-led operations that support compliance, improve efficiency and protect patients — wherever our clients operate.
Sunil VermaFounder & CEO, HAROM India LinkedIn
Vision
Shaping the future of global pharmacovigilance
- Expert-led, technology-assisted safety operations that are inspection-ready by design.
- Controlled, documented processes that make compliance evidence a by-product of daily work.
- End-to-end drug-safety capability available to organisations of every size.
Mission
Expert-led, AI-assisted pharmacovigilance for a safer tomorrow
- Advance PV with automation and qualified human oversight on every safety-critical decision.
- Reduce compliance risk and effort through controlled workflows and connected technology.
- Help organisations establish and run dependable PV systems.
- Keep every deliverable aligned with global health-authority expectations.
Standards
Excellence in quality and compliance
- Aligned to ICH and GVP, and to the expectations of EMA, FDA, MHRA, Health Canada, CDSCO and WHO PIDM member countries.
- Accuracy by design: automation reduces error; experts assure quality.
- Audit-ready frameworks: data integrity, traceability and documented decisions.
- Continuous improvement as regulations evolve.
Depth across the pharmacovigilance lifecycle.
Case processing
Intake to submission across spontaneous, solicited, literature and clinical sources.
Aggregate reporting
Periodic safety reports compiled from controlled case data.
Signal management
Detection, validation, evaluation and documentation aligned to GVP Module IX.
Regulatory and safety writing
Risk management, benefit-risk and authority responses.
PV quality and compliance
PSMF, QMS, procedures, audits and inspection readiness.
Regulatory submissions
ICH E2B(R3) submissions and acknowledgement tracking across authorities.
Three principles behind every engagement.
Quality and compliance philosophy
We build for inspection, not just for operation. Every activity runs under controlled procedures, with a strict audit trail and documented decisions.
Technology philosophy
Technology does the repetitive work; qualified people make every safety-critical decision. Designed to support 21 CFR Part 11 and EU Annex 11 controls.
Partnership approach
Engage us for a defined requirement, a complete workstream or an integrated PV operating model. We take responsibility for outcomes, not just delivery.
Contact
Talk to a HAROM PV expert.
info@haromindia.com · F-468, 3rd Floor, Industrial Area, Focal Point, Sahibzada Ajit Singh Nagar (Mohali), Punjab 140308