This blog highlights how we ensure PV Quality Assurance through comprehensive PV audits, vendor qualifications, and risk management strategies that are meticulously crafted to not only meet regulatory standards but also drive continuous improvement in pharmacovigilance operations.
Pharmacovigilance plays a critical role in safeguarding patient health by monitoring, assessing, and preventing adverse effects of pharmaceutical products. At Lambda, we are committed to upholding the highest standards of drug safety through our end-to-end pharmacovigilance services. From clinical trials to post-marketing surveillance, we ensure compliance with global regulations while prioritizing patient well-being.
Key PV Milestones in 2024
Our PV audits focus on critical processes that form the foundation of a robust safety system. These include:
- 110,700 Individual Case Safety Reports (ICSRs) Processed
- 544,313 Literature Articles Reviewed
- 21,597 Medical Information and Communication Center (MICC) Queries Handled
- 507 Periodic Adverse Drug Experience Reports (PADER) Submitted
- 283 Periodic Safety Update Reports (PSUR), Annual Safety Reports (ASR), ACOS, and Other Safety Reports Managed
- 234 Risk Management Plans (RMP) / Risk Evaluation and Mitigation Strategies (REMS) Developed
- 9 Development Safety Update Reports (DSUR) Compiled
- 1,463 Signal Detection Reports Generated
- 66 Pharmacovigilance System Master Files (PSMF) Maintained
- 2,526 xEVMPD Entries Completed
✅ Inspections and Audits
- 5 Regulatory Inspections (3 USFDA, 1 MHRA, 1 TMDA)
- 16 Client Audits
- 19 Internal, Vendor, and Business Partner Audits Conducted by PVQA
Driving Excellence in Drug Safety
Pharmacovigilance is a continuous process that requires vigilance, expertise, and a proactive approach. At Lambda, we leverage advanced technology and a highly skilled team to streamline safety monitoring, detect potential risks, and ensure regulatory compliance.
With increasing regulatory expectations and the growing complexity of drug safety management, we remain focused on delivering high-quality pharmacovigilance solutions. By enhancing our processes, adopting innovative safety monitoring techniques, and collaborating with global partners, we strive to improve patient safety and regulatory compliance worldwide.
Inspection & Audit Readiness
Being prepared for external inspections is a vital aspect of any PV system. We expertly provide comprehensive support during audits and inspections, offering expert consultancy and tailored training to ensure readiness and compliance. Additionally, we conduct thorough pharmacovigilance gap analyses to identify any shortcomings in existing PV systems, followed by detailed recommendations for corrective actions to achieve full regulatory compliance.
Extensive Experience:
Lambda Therapeutic Research provides comprehensive drug safety & pharmacovigilance services, encompassing all clinical and post-marketing phases. Our well-established PV framework ensures thorough safety monitoring and regulatory compliance for both clinical and commercial products, offering end-to-end support across the entire life cycle of medicinal products.
