Regulatory Affairs is fundamental in shepherding the groundbreaking treatments through the approval process, ensuring that they meet rigorous standards for safety and efficacy. Each year, the United States Food and Drug Administration (FDA) receives a considerable number of New Drug Applications (NDAs) and Biologic License Applications (BLAs). However, from 2011 […]
Clinical trial plays a vital role in evaluating the safety and effectiveness of nutraceutical products. Nutraceuticals, the fusion of nutrition and pharmaceuticals, are gaining popularity as natural compounds that offer health benefits and disease prevention. They also provide a crucial avenue for validating these innovative therapies, exploring their potential benefits, […]
Clinical Trial in Nutraceuticals, which combine nutrition and pharmaceutical properties, have gained significant attention in promoting physical health, immunity, and longevity. A nutraceutical is any substance that is a food or part of a food that provides medical or health benefits, in addition to its basic nutritional value. These products […]
Medical Device Design and Development In the process of developing and introducing new medical devices to the market, verifying the essential design features is crucial. Design verification, which involves testing, inspection, and analysis, is a necessary step to ensure compliance with quality management standards such as ISO 13485. Additionally, validating […]
Post marketing surveillance (PMS) refers to monitoring of device/drug performance after successful completion of the clinical studies and the implementation of suitable action to improve patient safety. It is conducted after product is approved for sale by the European Union Medical Device Regulation (EUMDR) and the United States (US). It […]
Clinical Trials – Massive innovation was seen in clinical trials in the past couple of years, abating the fear of COVID-19 spread. Countless benefits from finding preventive measures, therapeutic drugs to developing vaccines have given the industry a more prominent audacity to take larger challenges. Not only the doctors and […]
Post market clinical follow-up and Post-market surveillance (PMS) refers to the monitoring of medical devices after they have been cleared for sale and are in use by the public. One of the several types of post-marketing surveillance on the use of medical devices stipulated by the European Union Medical Device […]