Stay Audit-Ready with Expert-Led & AI-Powered PV Compliance
HAROM India ensures that your Pharmacovigilance systems and documentation are regulatory-compliant, inspection-ready, and fully traceable—with expert oversight and smart automation.
Audit Readiness
AI-Powered System
Expert Oversight
Audit Preparation Dashboard
Proven Expertise in End-to-End PV Audit Preparation
Robust audit preparation across all core PV activities—tailored to meet global regulatory expectations.
With a legacy of supporting global pharma, biotech, and CRO clients, HAROM India offers deep expertise in inspection planning, documentation review, mock audits, and real-time compliance tracking.
Our comprehensive audit readiness services cover:
- ●ICSR Case Management Documentation
- ●Aggregate Report (PSUR, DSUR, PBRER) Preparedness
- ●Signal Management & Risk Minimization Documentation
- ●Labeling and Safety Communication Logs
- ●Quality Management System (QMS) & SOP Audits
- ●Training Records & Compliance Logs
- ●Safety Database & Workflow Validation
- ●Third-Party PV Partner Oversight & Audit Support
- ●Literature Screening & Medical Writing Documentation
- ●Regulatory Submission & Reporting Compliance Audit
Whether you're preparing for EMA, FDA, CDSCO, MHRA, or internal audits, we've got you covered.
We are giving world-class services Since
2010
Zero Compromise on Compliance – Full Transparency & Control
Structured, quality-driven systems for stress-free inspections and global audit readiness.
ICH E6/E2E, GVP, and 21 CFR Part 11-aligned processes
Our processes adhere to all global regulatory standards
SOP-driven workflows and document traceability
Complete documentation with clear audit trails
Deviation, CAPA, and audit trail management
Comprehensive tracking and resolution systems
With HAROM India, you're not just ready for an audit—you're ahead of it.
Smarter Audits with AI-Enabled Compliance Checkers
Reduce manual errors, gain real-time insights, and automate readiness with smart tools.
HAROM India integrates intelligent automation into every stage of PV audit preparation. Our proprietary tools help you:
Save time, reduce effort, and gain deeper insights—without compromising on quality.
WHY CHOOSE US
End-to-End PV Audit Services
For Global Compliance Needs
Customizable solutions tailored to the complexity and maturity of your safety systems.
Mock Audits
Internal & External
SOP Review
Regulatory Gap Analysis
CAPA Planning
Implementation Support
Partner/Vendor
PV Audit Readiness
Remote Audit
Support Tools & Infrastructure
Training Readiness
Documentation Review
Audit Trail
Verification & Data Traceability
Regulatory Authority
Inspection Preparation
Audit Dashboard
Mock Audits
Internal & External
SOP Review
Regulatory Gap Analysis
CAPA Planning
Implementation Support
Partner/Vendor
PV Audit Readiness
Remote Audit
Support Tools & Infrastructure
Training Readiness
Documentation Review
Audit Trail
Verification & Data Traceability
Regulatory Authority
Inspection Preparation
From startups to global MNCs, we offer scalable and personalized audit support for every organization.
Let's Work Together
Tell Us Your PV Challenges – We'll Provide the Solution.