Pharmacovigilance (PV)
SciTechnologies team of highly qualified PV experts, combined with integrated technology, ensures that your product meets the highest levels of compliance with both regional and global pharmacovigilance regulations.
We are well equipped to expand as your business grows, guiding you through every step of the PV process and pivoting to meet your developing needs.
The Sciinov Group team is prepared to handle large case volumes and operates globally, supporting clients throughout the complete product lifecycle. Our PV services are available on a standalone basis or can be integrated with global Medical Information and Regulatory services.
We employ a robust professional staff of healthcare providers that work across a broad range of therapeutic areas. Our PV experts ensure safety and consistency throughout your clinical trials.
Benefits For Healthcare Players:
Clinical Pharmacovigilance:
• Safety Management Plan (SMP) Development
• Clinical Pharmacovigilance (PV) Auditing Services
• Individual Case Safety Reports (ICSR) Processing and Submission
• Aggregate Safety Report Generation and Reporting
• Data Safety Monitoring Board
• Medical Monitoring
Postmarketing Pharmacovigilance:
• Qualified Person for Pharmacovigilance (QPPV) and Local Person for Pharmacovigilance (LPPV)
• Individual Case Safety Reports (ICSR) Processing and Reporting
• Aggregate Safety Report Generation and Reporting
• Global and Local Literature Screening
• Signal Management
• Pharmacovigilance System Master File (PSMF) Development and Maintenance
• Risk Management Plan (RMP) Development and Maintenance
• Postmarketing Pharmacovigilance (PV) Auditing Services
• Named-Patient and Compassionate Use Programs
Have a business Query? Let's Talk.
Email : info@sciinovgroup.com or Call : +91 7997224449
India: 040-46013143
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