In an era where real-world data (RWD) is reshaping pharmacovigilance, the ability to detect and manage safety signals effectively has become a cornerstone of regulatory compliance and patient protection. With data flowing from electronic health
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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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The Evolving Pharma Landscape: Innovation Demands AgilityThe pharmaceutical industry is a dynamic ecosystem where innovation never sleeps. From advancements in manufacturing technologies to shifts in formulation strategies, post-approval changes are inevitable. Yet, every modification—whether to
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Discover expert tips to avoid costly FDA submission mistakes in 2025. Learn how to ensure compliance, improve documentation, and accelerate product approval.
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Is your clinical trial ready for ICH E6 (R3)? Discover the key areas to focus on, from risk-based quality management to digital transformation, and ensure compliance with the latest GCP guidelines.
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EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation
Read MoreHow CROs Can Support Pharmacovigilance and Regulatory Compliance? Pharmacovigilance is the process of monitoring, evaluating, and preventing adverse reactions or any other problems related to medicines. It is an essential part of drug development and
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