Pharmacovigilance Excellence

Fast, Accurate & Fully Compliant ICSR Processing Services

HAROM India provides end-to-end Individual Case Safety Report (ICSR) processing services ensuring 100% global compliance, accuracy, and efficiency—powered by AI-driven automation and expert regulatory oversight.

Enhance your Pharmacovigilance operations with faster case processing, reduced costs, and real-time compliance tracking.

Case Intake

Medical Review

Data Processing

Zero Errors

Global Compliance

AIPowered

HAROM India Expertise in ICSR Processing

Ensuring Accuracy, Compliance& Efficiency in Every Case

HAROM India specializes in high-quality ICSR processing solutions, offering expertise in:

Complete ICSR Lifecycle Management – From case intake, data entry, and medical review to regulatory submission.

Multi-Region Compliance – Adhering to global FDA, EMA, MHRA, CDSCO, and WHO reporting requirements.

MedDRA-Coded Case Processing – Ensuring accurate case classification and standardized reporting.

End-to-End Case Management – Managing serious & non-serious cases, literature cases, and clinical trial safety cases.

Comprehensive Quality Control – Ensuring zero processing errors & regulatory-compliant submissions.

Our experienced PV team ensures seamless, error-free, and globally compliant ICSR case handling.

Our Expertise →

HAROM India – Delivering Quality & Compliance in Every ICSR Case

100% Regulatory Compliance & Audit-Ready Case Processing

At HAROM India, we prioritize quality, accuracy, and global compliance in ICSR case processing:

Continuous Quality Monitoring

Global Regulatory Expertise

Our expert-driven approach ensures your cases are processed with accuracy, integrity, and full regulatory compliance.

Regulatory-Compliant Workflows

Meeting ICH E2B, GVP, 21 CFR Part 11, and global PV standards.

Multi-Level Quality Checks

Ensuring error-free data validation, medical coding accuracy & regulatory adherence.

Audit-Ready Documentation

Complete audit trails, revision tracking, and compliance transparency.

Comprehensive Data Integrity

Structured case documentation for seamless regulatory submissions.

AI-Powered ICSR Processing – Smarter, Faster & Fully Compliant

Enhancing ICSR Processing Efficiency with AI & Smart Automation

HAROM India leverages cutting-edge AI-driven automation to enhance ICSR processing speed, accuracy, and cost-efficiency:

AI-Powered Case Intake & Auto-Triage

Reducing manual effort and processing time.

Automated MedDRA Coding & Data Validation

Ensuring 100% accuracy & standardized reporting.

AI-Based Narrative Autofetch & Structuring

Generating well-formatted case narratives instantly.

Smart Workflow Automation & Predictive Risk Alerts

Optimizing efficiency and early identification of case priorities.

Reduce processing time, lower costs, and achieve real-time compliance with AI-powered ICSR automation.

Why Choose Us

HAROM India's End-to-End ICSR Processing

Expert-Led ICSR Processing Services for Regulatory Excellence

Case Intake & Data Entry

Structured case intake from clinical trials, spontaneous reports & literature sources.

Medical Review & MedDRA Coding

AI-enhanced coded case processing for regulatory standardization.

Serious & Non-Serious Case Management

Processing spontaneous, clinical, post-marketing & solicited reports.

Aggregate Report Line Listing

Seamless PV reporting for periodic safety updates.

Multi-Country Case Processing

Region-specific ICSR submission adhering to FDA, EMA, MHRA, CDSCO & WHO guidelines.

Regulatory Submissions

Automated case submissions to regulatory authorities and business partners.

HAROM India delivers scalable ICSR processing services with unparalleled speed, compliance, and efficiency.

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Tell Us Your PV Challenges – We'll Provide the Solution.