Introduction In today’s highly regulated pharmaceutical environment, a company’s pharmacovigilance system defines its credibility, transparency, and commitment to patient safety. At the heart of this system lies the Pharmacovigilance System Master File (PSMF) — a
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Medical device labelling is more than just a regulatory requirement—it’s a critical communication tool that ensures safety, usability, and compliance. Whether you’re a manufacturer, distributor, or healthcare provider, understanding the essential elements of clear and
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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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In today’s rapidly evolving pharmaceutical landscape, regulatory authorities around the world place increasing emphasis on drug safety. As a result, Qualified Person for Pharmacovigilance (QPPV) services have become a critical component of global pharmacovigilance systems.
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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.
Read MoreSeveral Emerging trends are shaping the Pharmacovigilance and Regulatory Affairs domains in 2025 making their collaboration even more critical: 1. Integration of Artificial Intelligence (AI) and Machine Learning (ML) AI and ML are revolutionizing both
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The world of medicine is constantly evolving, and pharmacovigilance, the science of monitoring drug safety, is no exception. Traditional methods of tracking adverse drug reactions (ADRs) often rely on manual review and passive reporting, which
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Here are the top 10 trends in pharmaceutical industry innovations to embrace in 2024 1. Rise in Pharmacovigilance Market: The pharmacovigilance market is expected to grow at a CAGR of 13.6% from 2021 to 2028.
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At Vigilare Biopharma We strongly believe that medications play a crucial role in modern healthcare, but their benefits are intricately linked to their safety. A robust pharmacovigilance system is vital to ensure that medications are
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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