The pharmacovigilance (PV) landscape is evolving rapidly, triggered by increasing data volumes, global collaborative efforts, and demanding data transparency expectations. Given the scenario, 2026 is expected to become a defining year for the Pharmaceutical industry
Read MoreFDA Pharmacovigilance Status Quo: Do you know? The Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (FAERS) contains 25 million adverse event reports in its database. The Agency processes more than 2 million ADRs
Read MoreIn the European Union (EU), rare diseases contribute to approximately 6-8% of total deaths across all age groups. The death percentage is about 35% among the pediatric population, especially in the first year of life,
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Pharmacovigilance 2026 is set to be a definitive platform for patient safety, featuring strengthened and automated vigilance systems. The future of Pharmacovigilance is poised for a transformative shift, driven by new avenues such as automation
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In today’s pharmaceutical ecosystem, pharmacovigilance (PV) has become more global, modular, and digitally enabled than ever before. Sponsors now rely on extended vendor networks CROs, BPOs, cloud technology partners, and niche safety-service providers. While these
Read More An Asia-based mid-sized pharmaceutical company sought to launch a generic anti-hypertensive drug in the U.S. market. With limited internal expertise in FDA submissions and facing a tight launch timeline, the client needed end-to-end support for
Read MoreA global medical device manufacturer needed to expand into multiple new markets across Europe, Middle East, and Asia-Pacific (EMEA & APAC). The challenge was to achieve quick and compliant registration of Class II and III
Read MoreA Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide. The project included 15+ global PV audits across 9 months, addressing inconsistent PV practices across
Read MoreA mid-sized U.S.-based pharmaceutical company approached Vigilare to rapidly implement a global safety database within an aggressive four-week timeline. The scope involved migrating 4,000+ legacy safety cases (some over 20 years old), supporting 4 affiliate
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From Vigilare Biopharma: The recent PRAC meeting (2-5 June 2025) underscores the relentless pace of pharmacovigilance evolution. From gene therapy safety to AI integration and refined risk management for established classes, the demands on sponsors
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