HAROM India

Streamlined Literature Management for Global PV Compliance

HAROM India offers expert-driven, Literature Management Services that ensure timely identification, review, and reporting of safety data from global scientific publications.

Literature Monitor

Publications1,247
Cases Found12

Processing

Screening
Review

HAROM India's Expertise in Literature Management Services

Comprehensive Literature Monitoring with Global Regulatory Alignment

Expert-led and tech-enabled solutions for tracking and reporting safety data from scientific publications.

HAROM India offers full-spectrum Literature Management Services to support pharmacovigilance and regulatory compliance across markets. Our team ensures accurate, timely review of literature sources aligned with ICH, GVP, and national regulatory requirements.

Our core expertise includes:

Global and Local Literature Surveillance
Automated Literature Searching and Screening
ICSR Identification & Extraction from Literature
Case Evaluation & Narrative Drafting
Aggregate Report Support (e.g., PBRER, PSUR)
Medical Assessment of Literature Cases
Maintenance of Search Strategies & Logs
Compliance with EMA, FDA, CDSCO, and WHO Guidelines

We help you meet regulatory obligations while reducing resource strain and minimizing compliance risks.

HAROM Technology and Literature Experts
Live Monitoring
Global Sources

OUR APPROACH

Accuracy. Audit-Readiness. Regulatory Confidence.

HAROM India delivers literature management services backed by SOP-driven workflows and robust QA processes.

1

Standardized Search Strategies Across Global Databases

2

Regularly Updated Literature Sources & Keywords

3

100% Traceability with Documented Search Logs

4

Periodic Quality Reviews and Medical Oversight

5

Timely ICSR Case Extraction & Reporting

6

Full compliance with GVP Module VI, ICH E2E, and EMA/FDA/WHO expectations

With HAROM India, your literature monitoring processes are always inspection-ready.

HAROM India Literature Management Specialist

All-in-One Literature Services Designed for Global PV Needs

Customizable and scalable services to meet the regulatory needs of every company.

Weekly & Monthly Literature Surveillance

Local & Global

ICSR Identification & Processing

From Publications

Case Narrative Preparation

From Scientific Articles

Literature Support

For Aggregate Reports

Literature Assessment

For Signal Detection

Search Strategy Development

& Documentation

Search Log Preparation

and Archiving

Audit-Ready Documentation

and Quality Checks

Medical Review

of Relevant Publications

No matter your company's size or market, HAROM India offers tailored solutions for comprehensive literature compliance.

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Let's Work Together

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