Ensuring the Safety of Pharmaceutical Products throughout their Lifecycle
Umbra Quality Systems recognizes the paramount importance of Pharmacovigilance in the pharmaceutical industry. Our Pharmacovigilance services are designed to systematically monitor and assess the safety of pharmaceutical products, contributing to the overall safety of patients and regulatory compliance.
The Crucial Role of Pharmacovigilance
Pharmacovigilance involves the collection, assessment, monitoring, and prevention of adverse effects or any other drug-related problems. It is a fundamental aspect of ensuring the safety and efficacy of pharmaceutical products throughout their lifecycle, from development to post-market surveillance.
Our Comprehensive Pharmacovigilance Solutions
1. ICSR case reporting and follow up:
Reporting adverse events as per the regulatory guidelines.
2. Aggregate Reporting:
Periodic safety update reports (PSUR). Contextual Benefit Risk evaluation
3. Risk Management Plan
Establish risk management plans based on the product portfolio.
4. QPPV Services
-Establish and maintain Pv System master file(PSFMF)
-Ensure compliance with PV regulations and guidelines
-Risk assessment and management
-Establish Good Documentation Practices
-Collection, evaluation and reporting and communication of adverse events and safety data
-Training of personnel on Pv Principles
-Establish Safety Data Exchange Agreements for Stakeholder engagement
-Align Pv system with other key areas such as QA
-Product Benefit Risk Evaluation
Advantages of Choosing Umbra Quality Systems for Pharmacovigilance:
- Patient Safety Priority: Our pharmacovigilance services prioritize patient safety, contributing to the overall well-being of those using pharmaceutical products.
- Regulatory Compliance:* Ensure compliance with global pharmacovigilance regulations through our systematic and accurate reporting processes.
- Proactive Risk Management:* Identify and address potential risks associated with pharmaceutical products, contributing to proactive risk management.
Safeguard Patient Well-being with Pharmacovigilance
Prioritize the safety and well-being of patients with Umbra Quality Systems’ Pharmacovigilance services. Contact us to explore how our pharmacovigilance solutions can contribute to the success and safety of your pharmaceutical products.