HAROM

HAROM India Pvt. Ltd

@harom_solutions

Mohali, Punjab
http://www.haromindia.com
Outsourcing and Offshoring Consulting

Overview

About HAROM India Pvt. Ltd

At HAROM India, we are redefining the future of Pharmacovigilance and Regulatory Compliance through intelligent, audit-ready, and globally aligned solutions.

As India’s first provider of a ready-to-deploy Pharmacovigilance System, HAROM India empowers pharmaceutical and biotech organizations to achieve inspection-ready compliance in record time — with AI-driven automation, expert consulting, and regulatory precision.

Our comprehensive portfolio spans every layer of drug safety and compliance management:
• Pharmacovigilance System Setup – End-to-end establishment of CDSCO- and EMA-compliant PV systems, including PSMF, SOP frameworks, and workflows.
• Safety Database Solutions – Implementation of HAROM Safety Vault, a 21 CFR Part 11–compliant, AI-powered database for case management, narrative automation, and signal tracking.
• Regulatory Consulting & Audit Readiness – Hands-on advisory and compliance programs to prepare organizations for local and global inspections.
• Training & Capacity Building – Customized programs for PV teams, QPPVs, and regulatory professionals through digital learning and live workshops.

Driven by innovation and backed by industry expertise, HAROM India bridges the gap between technology, compliance, and patient safety. Our approach simplifies complexity, reduces timelines, and ensures seamless adherence to CDSCO, EMA, FDA, and ICH regulations.

Our mission is simple yet powerful — to make global Pharmacovigilance accessible, intelligent, and future-ready for every pharma company in India and beyond.

Headquarters

Mohali, Punjab

Website

http://www.haromindia.com

Company Size

11-50 employees

Industry

Outsourcing and Offshoring Consulting

Company Type

Privately Held

Founded

2026

Specialties

AI-Driven Pharmacovigilance Solutions, Ready-to-Deploy PV System Setup, PSMF Development & Management, SOP & Workflow Framework Design, Global Regulatory Compliance (CDSCO, EMA, FDA), Audit Readiness & Inspection Support, HAROM Safety Vault – Safety Database Implementation, ICSR Processing & Case Management Automation, Aggregate Report Development (PBRER, PSUR, DSUR), Signal Detection & Risk Management, QPPV & PV Governance Advisory, PV Quality Management Systems (QMS), CAPA & Deviation Management, AI-Based Literature Screening Solutions, Compliance Analytics & Metrics Monitoring, PV Training & Capacity Building, Digital Learning for PV Teams & QPPVs, Regulatory Strategy & Submission Support, Global PV System Integration for Pharma & Biotech, and End-to-End Drug Safety Consulting

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