Pharmacovigilance Research Outsourcing Services
Our pharmacovigilance research outsourcing services help pharmaceutical and biotech companies maintain drug safety, detect risks early, and comply with global regulatory requirements throughout the product lifecycle.
Our Pharmacovigilance Research Capabilities
Our pharmacovigilance experts, medical writers, and regulatory professionals use advanced safety databases, signal detection tools, and global compliance workflows to deliver robust drug safety data management.
Types of Pharmacovigilance Research We Handle
- Adverse Event Case Processing
- Serious Adverse Event (SAE) Management
- Signal Detection and Assessment
- Risk Management Plan Development
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Individual Case Safety Reports (ICSRs)
- Literature Surveillance and Screening
- Safety Database Management
- Medical Review of Safety Data
- Aggregate Safety Data Analysis
- Regulatory Submission Support
- Post-Marketing Surveillance
- Pharmacoepidemiology Studies
- Safety Signal Quantitative Analysis
- Benefit-Risk Analysis and Evaluation
- Compliance and Audit Preparation
- Safety Labeling Updates
- Regulatory Authority Query Handling
- Adverse Drug Reaction (ADR) Reporting
- Vigilance System Master File (VSMF) Preparation
- Third Party Safety Data Reconciliation
- Medical Information Call Center Support
- Social Media Monitoring for Safety Signals
- Real-World Evidence Safety Analytics
- Training and Compliance Workshops
- Cross-Functional Safety Team Collaboration
- Publication-Ready Pharmacovigilance Reports
- Custom Pharmacovigilance Research Projects
Key Research Outsourcing Services Offered
- Adverse Event and SAE Case Processing
- Signal Detection and Quantitative Analysis
- Literature Surveillance and Abstracting
- Risk Management Plan Development
- Aggregate Safety Report Generation
- ICSR and E2B XML Submissions
- Post-Marketing Safety Monitoring
- Safety Data Reconciliation with CROs
- Medical Review and Narrative Writing
- Pharmacoepidemiology Data Analysis
- Safety Labeling and Updates
- Regulatory Response Support
- Compliance with GVP and ICH Guidelines
- Confidential Data Handling and NDA
- Interim Reports and Progress Updates
- Publication-Ready Safety Reports
- Stakeholder Presentation Support
- Workshops and Training for PV Teams
- Post-Project Technical Consulting
- IP and Patent Filing Support
- Grant Proposal and Manuscript Assistance
- Sample Archiving and Secure Backup
- Audit Preparation and Readiness
- Cross-Lab Data Validation and Sharing
- Collaboration with Regulatory Affairs Teams
- Long-Term PV Research Partnerships
- Custom Safety Data Visualization Dashboards
- Real-World Evidence Signal Mining
- Patient Safety Communication Support
- Social Media and Digital Safety Monitoring
Why Choose Us for Pharmacovigilance Research Outsourcing?
Our end-to-end PV services ensure patient safety, regulatory compliance, and transparent safety data reporting, supporting your drug products from development to post-market phases.
Industries & Sectors We Serve
- Pharmaceutical and Biotech Companies
- Generic Drug Manufacturers
- Contract Research Organizations (CROs)
- Regulatory Affairs and Compliance Firms
- Pharmacoepidemiology Research Centers
- Patient Safety and Advocacy Groups
Customized Pharmacovigilance Solutions
We tailor safety monitoring frameworks, reporting pipelines, and regulatory documentation workflows to align with your product portfolio and market-specific compliance needs.
Quality Assurance & Regulatory Compliance
Our workflows comply with GVP, ICH, EMA, US FDA, and global PV guidelines, ensuring robust, reproducible, and audit-ready pharmacovigilance operations.
Case Studies & Client Success Stories
See how our outsourcing has enhanced signal detection, streamlined safety reporting, and ensured successful regulatory audits for global pharma companies. References available on request.
How It Works: Our Research Outsourcing Process
- Requirement Gathering: Define product portfolio, safety scope, and compliance targets.
- Proposal & Quotation: Provide detailed plan, timelines, and cost estimates.
- Safety Data Collection & Analysis: Process AE/SAE cases, conduct signal detection, and prepare reports.
- Reporting: Deliver regulatory-ready submissions and stakeholder reports.
- Post-Project Support: Offer audit support, training, and ongoing safety monitoring advisory.
Frequently Asked Questions (FAQs)
Q: Do you handle global ICSR submissions?
A: Yes — we manage E2B compliant ICSR processing and global health authority submissions.
Q: Can you design custom risk management plans?
A: Absolutely — we develop RMPs aligned with product profiles and regulatory guidelines.
Q: How secure is patient safety data?
A: We guarantee strict NDAs, encrypted storage, and full compliance with GDPR and HIPAA.
Get Started / Request a Quote
Contact us today to discuss your pharmacovigilance needs and receive a custom plan, timeline, and cost estimate aligned with your safety compliance goals.
Contact Us
Email: research-outsourcing@nthrys.com
Phone: +91-8977624748
Contact Us