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Comprehensive Drug Safety Surveillance Solutions
End-to-end pharmacovigilance services delivering regulatory compliance, patient safety monitoring, and risk management excellence across global markets with ISO-certified quality standards.
Comprehensive Service Portfolio
End-to-end pharmacovigilance solutions delivering regulatory compliance, patient safety monitoring, and risk management excellence
PSMF Services
Complete lifecycle management ensuring MAHs remain compliant with EU/EEA legal requirements.
- Complete PSMF preparation and authoring
- Day-to-day maintenance and continuous updates
- 7-day availability for NCA inspections
- Quality assurance and gap analysis
- EMA GVP Module II compliance
QPPV Services
Rapidly expanding network of experienced QPPVs and LPPVs supporting global market entry strategies.
- EU-QPPV and Deputy QPPV services
- Local Safety Officers (India, EU, CIS, MENA, LATAM)
- Local regulatory intelligence monitoring
- Primary contact for competent authorities
- KPI tracking and compliance monitoring
ICSR Processing
End-to-end case management with 100% QC and pharmacovigilance physician review.
- Case triage, data entry, and processing
- 100% QC by independent reviewers
- Medical review by PV physicians
- Expert coding (MedDRA, WHO-DD, ICD)
- Regulatory submission and follow-up
Literature Monitoring
Weekly and ongoing searches with systematic identification and processing of literature-derived ICSRs.
- Weekly searches (PubMed, Embase, Cochrane)
- Identification and triage of literature ICSRs
- Seamless case processing integration
- 100% reconciliation procedures
- PSUR-relevant literature searches
Signal Detection
AI-powered analysis with disproportionality methods, clinical review, and complete signal lifecycle management.
- AI-driven predictive signal detection
- Statistical analysis (PRR, ROR, IC)
- Signal evaluation and prioritization
- Regular medical monitoring
- Comprehensive assessment reports
Aggregate Reports
Complete authoring of PBRERs, PSURs, DSURs, ASRs, SBRs with calendar management and compliance monitoring.
- PBRER, PADER, PSUR, DSUR authoring
- ASR, SBR, and addendum preparation
- IBD, DLP tracking and calendar management
- Benefit-risk evaluation and analysis
- Compliance monitoring and reporting
Cost-Effective Excellence
Significant cost reduction without compromising quality, delivering ISO-certified workflows with 99.8% data accuracy.
Cost Comparison
Cost savings result from shared infrastructure, specialized expertise, scalable resources, and operational efficiencies. Eliminate personnel, system licenses, and infrastructure costs.
Emergency Compliance Program
Fully functional pharmacovigilance system implemented in 30 days for companies facing immediate regulatory action or license suspension risks.
Addressing urgent compliance needs amid intensified regulatory enforcement in Indian pharmaceutical market.
Risk Management Plans & Minimization
Comprehensive RMP authoring with safety specifications, pharmacovigilance plans, and innovative risk minimization strategies
Complete RMP Development
EU RMP and FDA REMS preparation meeting regulatory requirements across global jurisdictions.
Safety Specification
Important identified risks, potential risks, and missing information with comprehensive characterization.
Pharmacovigilance Plan
Routine and additional PV activities including PASS, enhanced monitoring, registries, and targeted surveillance.
Risk Minimization Measures
Routine measures (product information, legal status) and additional aRMMs targeting specific safety concerns.
European Risk Management Plans
Risk Evaluation & Mitigation Strategies
Additional Risk Minimization
Analysis & Optimization
Educational Materials Development
Comprehensive materials for healthcare professionals and patients with user testing and effectiveness analysis.
Direct Healthcare Communications
Urgent safety communications to prescribers with clear action recommendations and reporting mechanisms.
Direct Healthcare Professional Communications
Regulatory consultation and stakeholder review
Plain language materials with health literacy assessment
Safety Data Exchange & Partnership Management
Customized SDEAs with complete reconciliation and compliance monitoring across global partnerships
SDEA Preparation & Review
Customized Safety Data Exchange Agreements tailored to country-specific regulatory requirements.
- Clear definition of responsibilities for case collection and reporting
- Data exchange formats, timelines, and quality standards
- Country-specific provisions and language specifications
- Review and negotiation support with PV expertise
Reconciliation & Compliance
Regular reconciliation procedures ensuring complete data exchange and partner compliance.
- Case listing comparisons and duplicate identification
- Timeline compliance verification
- Formal reconciliation reports with discrepancy resolution
- Process setup ensuring SDEA compliance
Technology-Powered Pharmacovigilance Solutions
Leveraging AI, machine learning, and automation to deliver superior safety monitoring and regulatory compliance
AI & Machine Learning
Predictive signal detection and automated case processing with continuous learning from historical data.
- Natural Language Processing for extraction
- Predictive safety signal detection
- Automated case triage and coding
- Social media and EHR monitoring
Real-Time Dashboards
Comprehensive visibility into operations, compliance metrics, and quality indicators with automated alerts.
- Live compliance and KPI dashboards
- Case intake and processing status
- Quality metrics and trend analysis
- Customizable stakeholder views
Secure Integration
Seamless connectivity with global safety databases and regulatory portals with complete audit trails.
- E2B(R3) electronic reporting
- VigiBase, FAERS, EudraVigilance
- Automated regulatory submissions
- Complete audit trail documentation
Automated Case Processing
NLP-powered extraction from unstructured sources with automated coding, duplicate detection, and quality checks.
Automated Data Extraction
From MedWatch forms, HCP letters, and patient reports
Initial Coding Suggestions
MedDRA and WHO-DD automated coding support
Quality Validation
Duplicate detection and data quality checks
Integration Capabilities
Quality & Compliance Excellence
ISO-certified workflows delivering 99.8% data accuracy with comprehensive audit and inspection readiness
ISO Certified
Standardized processes with continuous improvement and QMS implementation.
GVP Audits
Comprehensive Good Pharmacovigilance Practice audits and self-inspections.
CAPA Management
Root cause analysis with corrective and preventive action implementation.
Gap Analysis
System assessments against regulatory requirements and best practices.
Regulatory Compliance Across Jurisdictions
Expert knowledge and proven track record across global regulatory frameworks.
15-day and 90-day reporting via Sugam Portal with zero-tolerance compliance
MedWatch reporting, REMS implementation, and FDA safety inquiry responses
GVP Module compliance and national competent authority requirements
E2A through E2F implementation for multi-regional compliance
Pan-India & Global Presence
Comprehensive coverage across India with international expertise in multiple regions.
Regional Expertise
EU, CIS Countries, MENA, and LATAM regional coverage
Quality Management Systems
Comprehensive QMS development and implementation with ICH Q9 quality risk management principles.
- Quality policy and organizational responsibilities
- Management review and continual improvement
- Personnel training and competency assessment
- Document and records control
- Change management and deviation handling
SOP Development & Management
Complete suite of regulatory-compliant SOPs covering all pharmacovigilance processes with periodic review and updates.
- Case processing and reporting procedures
- Signal detection and management
- Aggregate report preparation
- Safety data exchange agreements
- Audit and inspection readiness
Comprehensive Safety Writing Services
Expert medical writing delivering high-quality regulatory and scientific documentation with physician review and validation
Core PV Documents
- DSUR, PBRER, PSUR authoring
- RMP and REMS preparation
- PSMF maintenance
- Signal assessment reports
Literature Documents
- Clinical study reports
- Investigator Brochures
- Systematic literature reviews
- Meta-analyses
Regulatory Submissions
- Response to regulatory queries
- Product labeling updates
- Safety sections for CTD/eCTD
- Expert reports
Physician-Validated Medical Writing
All documents undergo rigorous medical review by qualified pharmacovigilance physicians ensuring clinical accuracy, regulatory compliance, and scientific rigor.
Ready to Elevate Your Pharmacovigilance?
Partner with Cliorbit for comprehensive drug safety solutions that deliver regulatory compliance, patient protection, and operational excellence with proven cost savings.