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The global medical device industry is a dynamic and fast-growing sector, expected to surpass $800 billion by 2030. While innovation and regulatory compliance are cornerstones of this growth, there’s another crucial factor that determines the success of any medical device — market access. Without a well-defined market access strategy, even the most groundbreaking devices may fail to […]
As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical pillar of lifecycle management in medical devices. In the times where real-world performance, patient safety, and global compliance are under the spotlight, PMS is a strategic advantage. […]
Drug safety revolves around ensuring that the right patient receives the right medication at the right time, leading to optimal treatment outcomes. To support this goal, a Qualified Person Responsible for Pharmacovigilance (QPPV) plays a critical role in overseeing the quality and compliance of a pharmaceutical company’s pharmacovigilance system. This individual must take a proactive […]
Pharmacovigilance plays a critical role in the healthcare industry, ensuring that medicines are safe and effective for the public. As the use of pharmaceuticals continues to increase globally, so does the importance of robust pharmacovigilance services. These services help monitor, assess, and report adverse drug reactions (ADRs), ultimately contributing to the improvement of patient safety. In […]
Introduction In the rapidly evolving pharmaceutical landscape of India, ensuring the safety and efficacy of drugs is paramount. This is where pharmacovigilance and regulatory services play a crucial role. These services not only protect public health by monitoring adverse drug reactions but also help pharmaceutical companies navigate the complex regulatory frameworks essential for launching new drugs. What […]