Stay Ahead of Risks with Smart Signal Detection & Minimization
Smarter Signal Management Starts Here
Ensure patient safety and regulatory compliance with HAROM India's expert-led and regulatory complaint Signal Management & Risk Minimization services.
Signal Detection
Risk Assessment
Signal Detection
Advanced AI algorithms to identify potential safety signals
Risk Management
Comprehensive strategies to minimize identified risks
Regulatory Compliance
Stay aligned with global safety standards and requirements
Expertise You Can Trust in Every Signal You Track
End-to-end solutions for timely detection, evaluation, and mitigation of safety signals.
With a team of highly experienced Pharmacovigilance professionals, HAROM India delivers end-to-end services for Signal Management & Risk Minimization aligned with global regulatory expectations.
Signal Management
- Signal Detection & Validation
- Signal Prioritization & Assessment
- Signal Confirmation & Communication
- Documentation & Signal Tracking Systems
- Quantitative & Qualitative Signal Analysis
Risk Minimization
- Risk Management Plan (RMP) Creation & Updates
- Risk Minimization Measures (RMMs) Implementation
- Effectiveness Evaluation of RMMs
- Periodic Benefit-Risk Evaluation Reports
- Product Labeling Updates Based on Signal Assessment
With HAROM India, ensure every potential safety signal is managed proactively, thoroughly, and compliantly.
Your Compliance Partner in Signal & Risk Oversight
Ensuring 100% regulatory alignment in every signal detection and risk mitigation process.
Our approach is backed by deep regulatory knowledge and robust SOPs in line with:
- ICH E2E, GVP Module IX, EMA & FDA requirements
- Fully audit-ready documentation and traceability
- Standardized signal management plans and communication pathways
- Cross-functional collaboration between medical, regulatory, and safety teams
- Periodic review and validation of signal data
HAROM India brings a compliance-first mindset to ensure all deliverables pass the scrutiny of global regulatory authorities.
Full-Spectrum Risk Oversight – From Detection to Resolution
HAROM India offers tailored services to meet diverse client needs in safety signal lifecycle and risk mitigation.
Signal Detection & Validation
Comprehensive identification and validation of potential safety signals from multiple data sources.
Signal Assessment Reports
Detailed analysis and confirmation reports with evidence-based recommendations.
Benefit-Risk Analysis
Thorough evaluation of benefits versus risks with strategic recommendations.
RMP Development
Creation and monitoring of comprehensive Risk Management Plans aligned with regulations.
Risk Minimization Measures
Design and implementation of effective Risk Minimization Measures (RMMs).
Educational Materials
Creation and distribution of educational materials for healthcare professionals and patients.
Effectiveness Evaluation
Periodic review and effectiveness checks of implemented risk minimization measures.
Labeling Impact Assessment
Evaluation of labeling changes based on new safety information and signals.
Let's Work Together
Tell Us Your PV Challenges – We'll Provide the Solution.