Your Trusted Partner in Drug Safety Excellence

· 24/7 safety monitoring and case processing.

· Comprehensive SAE/AE case handling including database entry, medical coding, and customized case narratives.

· Expedited safety reporting with MedWatch and CIOMS forms.

· Cross-reporting and similar event analysis.

· Rapid identification and processing of Suspected Unexpected Serious Adverse Reactions.

· Regulatory submission within required timelines (7 days for life-threatening events, 15 days for others).

· Cross-border reporting coordination.

· Project-specific safety management plan preparation.

· Comprehensive training for investigators and clinical monitors on SAE/AE reporting procedures.

· Ongoing protocol compliance support.

· Annual safety report preparation following ICH E2F guidelines.

· Comprehensive data analysis and medical review.

· Timeline management with delivery 50 days post-DIBD.

· Regulatory-compliant risk assessment and mitigation strategies.

· Continuous risk-benefit evaluation.

· Risk minimization measure implementation.

· Regular safety data compilation and trend analysis.

· Signal detection and evaluation.

· Proactive risk identification.

· Local proxy submission for overseas cross-reports.

· Global coordination with international partners.

· Multi-regional regulatory compliance.

· Continuous post-marketing surveillance

· Spontaneous adverse event collection and processing

· Regulatory authority reporting compliance

· Advanced statistical signal detection methodologies

· Medical evaluation and causality assessment

· Risk characterization and communication

· ICH E2C(R2) compliant periodic reports

· Global safety database analysis

· Benefit-risk assessment updates

· Comprehensive RMP development and maintenance

· Additional risk minimization activities (aRMMs)

· Effectiveness monitoring and evaluation

· Study design and protocol development

· Safety data collection and analysis

· Regulatory reporting and communication

· Data sharing agreement implementation

· Partner safety data reconciliation

· Global affiliate coordination

· PV system establishment and maintenance

· Audit preparation and support

· Regulatory inspection readiness

· Pregnancy exposure registries

· Pediatric and geriatric safety monitoring

· Product-specific safety programs

· Emergency response procedures

· Regulatory authority communication

· Stakeholder notification protocols

· End-to-end PV system setup

· Quality management system implementation

· SOPs and process documentation

· Registration submission support

· Post-marketing commitment fulfillment

· Regulatory strategy development

· Statistical methodology selection

· Medical evaluation expertise

· Risk communication strategies

· Case processing workflow optimization

· Quality assurance procedures

· Database management solutions

· Customized training programs

· Mock audit exercises

· Compliance gap analysis

· Multi-regional strategy alignment

· International regulatory liaison

· Global safety database management

· Emergency response planning

· Communication strategy development

· Stakeholder management protocols

• Zero Major Findings: 100% pass rate of sponsor audits since 2019 with no major deficiencies identified.

• 100% On-Time Delivery: No delayed reports in our operational history.

• Perfect Compliance: Flawless consistency check completions across all projects.

• 500+ Pharmacovigilance Documents processed with meticulous attention to detail.

• 5,000+ Clinical Trial ICSRs managed across diverse therapeutic areas.

• 3,000+ Post-Marketing ICSRs handled with regulatory precision.

• Oncology (Solid Tumors & Hematologic Malignancies): 58 projects

• Endocrinology & Cardiovascular: 36 projects

• Respiratory & Hematology: 28 projects

• Ophthalmology & Rare Diseases: 26 projects

• Other Therapeutic Areas: 17 projects

• 24/7 Operations: Round-the-clock safety monitoring with dedicated shift management.

• Rapid Response: Immediate processing and feedback on all safety reports.

• Regulatory Expertise: Deep knowledge of global regulatory requirements and local regulations.

• Medical Excellence: Experienced clinical physicians with 10+ years of frontline medical experience.

• Robust SOP Framework: Comprehensive standard operating procedures covering all PV activities.

• Advanced Database Systems: State-of-the-art safety database configuration and management.

• Quality Control: Multi-level review processes ensuring accuracy and compliance.

• Continuous Training: Regular updates on regulatory changes and best practices.

• International Collaboration: Seamless coordination with global partners for cross-border reporting.

• Multi-Regional Expertise: Experience with FDA, EMA, NMPA, and other regulatory authorities.

• Language Capabilities: Professional translation services for international submissions.

• Cultural Competency: Understanding of regional regulatory nuances and requirements.

• Advanced Database Configuration: Customized safety database setup and maintenance.

• Automated Workflows: Streamlined processes for improved efficiency and accuracy.

• Electronic Submissions: Modern e-submission capabilities for regulatory authorities.

• Data Analytics: Advanced signal detection and trend analysis capabilities.