Global Pharmacovigilance Services for Drug Safety, Regulatory Compliance, and Lifecycle Risk Management
Pharmacovigilance (PV) is a critical component of pharmaceutical product lifecycle management, ensuring continuous monitoring, assessment, detection, understanding, prevention, and reporting of adverse events and safety risks associated with medicinal products.
Maven Regulatory Solutions provides comprehensive Pharmacovigilance Services that support organizations throughout the entire product lifecycle—from clinical development and market authorization to post-marketing surveillance and risk management.
Our pharmacovigilance experts deliver scalable, compliant, and cost-effective solutions covering Individual Case Safety Report (ICSR) processing, aggregate safety reporting, signal detection, literature monitoring, risk management plans, pharmacovigilance system development, regulatory submissions, and global safety surveillance.
Our Pharmacovigilance Services
1. End-to-End Pharmacovigilance Services
- Global Pharmacovigilance Outsourcing
- Drug Safety Surveillance
- Pharmacovigilance Consulting
- Pharmacovigilance Audits
- Compliance Assessments
- Global Safety Reporting
- PV System Setup
- Regulatory Inspection Readiness
- SOP Development
- Vendor Oversight Programs
- PV Quality Management Systems
2. Individual Case Safety Report (ICSR) Processing
- Case Intake & Triage
- Adverse Event Processing
- Serious Adverse Event Reporting
- Medical Assessment
- MedDRA Coding
- Narrative Writing
- Follow-up Activities
- Regulatory Submission Management
- E2B(R3) Compliance
- Safety Database Management
3. Aggregate Safety Reporting Services
PSUR Preparation Services- PSUR Planning
- Data Analysis
- Benefit-Risk Evaluation
- Regulatory Submission
- Health Authority Responses
- Safety Data Review
- Risk Assessment
- Benefit Evaluation
- Signal Integration
- Regulatory-Compliant Authoring
- Clinical Development Safety Reviews
- Regulatory Reporting
- Safety Trend Analysis
- Development Program Risk Assessments
4. Signal Detection & Management
- Signal Detection
- Signal Validation
- Signal Prioritization
- Signal Evaluation
- Signal Documentation
- Regulatory Reporting
- Signal Tracking
- Signal Closure Activities
5. Literature Monitoring Services
- Global Literature Surveillance
- Weekly Literature Screening
- Medical Journal Monitoring
- Local Literature Monitoring
- Case Identification
- Safety Signal Identification
- Literature Case Processing
- Regulatory Documentation
6. Medical Review Services
- Medical Case Review
- Causality Assessment
- Expectedness Assessment
- Seriousness Evaluation
- Benefit-Risk Analysis
- Clinical Safety Evaluation
7. Risk Management Plan (RMP) Services
- RMP Development
- EU-RMP Preparation
- Risk Minimization Measures
- Safety Concerns Evaluation
- PASS Support
8. Pharmacovigilance System Master File (PSMF)
- PSMF Development
- PSMF Maintenance
- Annex Updates
- Compliance Reviews
- Inspection Readiness Support
9. EU QPPV Services
- EU QPPV Support
- Local Contact Person Services
- Oversight Activities
- Regulatory Communications
- Inspection Support
10. Pharmacovigilance Audits & Inspection Readiness
- Pharmacovigilance Audits
- Mock Regulatory Inspections
- CAPA Development
- Inspection Readiness Programs
- Vendor Audits
- Affiliate Audits
Industries We Serve
- Pharmaceutical Companies
- Generic Drug Manufacturers
- Biotechnology Companies
- Biosimilar Manufacturers
- Vaccine Manufacturers
- Medical Device Combination Products
- CROs and MAHs
Our Pharmacovigilance Process
- Pharmacovigilance Assessment
- Gap Analysis
- Strategy Development
- Safety Operations Implementation
- Regulatory Compliance Management
- Continuous Safety Oversight
Why Choose Maven Regulatory Solutions?
- Global Pharmacovigilance Expertise
- Experienced Drug Safety Professionals
- Medical & Regulatory Specialists
- Scalable Outsourcing Models
- Inspection Readiness Support
- Dedicated Safety Teams
- Cost-Effective PV Solutions
- 24/7 Case Processing Support
- End-to-End Lifecycle Management
Request a Free Pharmacovigilance Consultation
Ensure global drug safety compliance with confidence. Our team provides expert support for pharmacovigilance, aggregate safety reporting, signal detection, literature monitoring, audits, compliance management, and outsourcing services.
