Despite being an established practice in the pharmaceutical industry, the question ‘What is Pharmacovigilance?’ remains a frequently asked one among the general public, students, and healthcare professionals, including doctors and nurses, in developing regions.  Whether
Read MorePharmacovigilance (PV) Regulation (EU) 2025/1466 is not just an annotation to Regulation (EU) 520/2012. It is a key arrangement for MAHs to understand how seriously they should work on safety systems (design, contract, audit, and
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
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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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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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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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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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EU GPSR (General Product Safety Regulation) The EU GPSR General Product Safety Regulation is a regulatory framework in the European Union that aims to ensure that products placed on the market are safe for consumers.
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Each country has unique regulations and documentation requirements, making it essential to develop a comprehensive strategy to ensure compliance across various regions. Here are some key strategies and tools to streamline the global regulatory submissions
Read MoreHyderabad, the capital of Telangana, has emerged as a prominent pharma hub in India, attracting global pharmaceutical companies and investors. Its strategic location, coupled with a favourable business environment, has made it a preferred destination
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