Post-market surveillance (PMS) is the central aspect of MDR compliance. It gives the device manufacturer a structured way to monitor device safety and performance in real-world use throughout the device lifecycle. The device manufacturer can
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Most companies don’t think about pharmacovigilance until they’re forced to. A product gets approved, the first adverse event report lands in someone’s inbox, and suddenly, there’s a scramble to figure out: who owns the process,
Read MoreIndia’s pharmaceutical market continues to expand, and with the growth comes greater responsibility for drug safety oversight. The Central Drugs Standard Control Organization (CDSCO) plays a central role in shaping the country’s pharmacovigilance framework. Key
Read MoreIdeating, researching, and developing a drug or biologic product and bringing it to market is not a simple process. From preclinical discovery through market authorization, every stage of the drug lifecycle is critical. Across the
Read MoreWhy PV Mandates Matter in 2026? Pharma manufacturers are rapidly launching their products across borders, directly intensifying the burden on safety monitoring. On the other hand, to enable quick signal detection, the PV processes are
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
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