Blogs

In today’s fast-paced technological landscape, the pharmaceutical and medical device sectors stand out as leaders in adopting state-of-the-art innovations. The Food and Drug Administration (FDA) has recognized the crucial role played by Advanced Manufacturing Technologies (AMT) in shaping the future of healthcare. This article delves into the significance of the FDA’s AMT Designation. We will try …

Health Canada is responsible for developing, researching, and marketing safe and quality medications inside the territories of Canada. This federal or national agency ensures that the Canadian Drug supply is protected, and people can access the medications. This guidance, GUI-0145, is intended to reduce the drug shortage that Canada is facing in the current stages. An Interim Order respecting drug …

Health Canada is responsible for developing, researching, and marketing safe and quality medications inside the territories of Canada. This federal or national agency ensures that the Canadian Drug supply is protected, and people can access the medications. This guidance, GUI-0145, is intended to reduce the drug shortage that Canada is facing in the current stages. An Interim Order respecting drug …

In this era of technological revolution, the pharmaceutical and medical device industries are at the forefront of embracing cutting-edge innovations. The Food and Drug Administration (FDA) acknowledges the pivotal role that Advanced Manufacturing Technologies (AMT) play in shaping the future of healthcare. This blog post delves into the significance of the FDA’s Advanced Manufacturing Technology …

In this era of technological revolution, the pharmaceutical and medical device industries are at the forefront of embracing cutting-edge innovations. The Food and Drug Administration (FDA) acknowledges the pivotal role that Advanced Manufacturing Technologies (AMT) play in shaping the future of healthcare. This blog post delves into the significance of the FDA’s Advanced Manufacturing Technology …

Considering the COVID-19 pandemic, the Food and Drug Administration (FDA) has introduced new guidelines and regulations to adapt to the changing landscape of the pharmaceutical industry. One significant development is the remote regulatory assessment (RRA) conducted for industry guidance by the FDA. This approach allows for conducting regulatory assessments remotely. This will result in minimizing …

The pharmaceutical industry plays a crucial role in society, developing and delivering life-saving medications. But navigating this complex field requires understanding its core principles. One framework often used to explain pharma’s foundation is the “The 5 P’s of Pharma”: People, products, processes, premises, and procedures. Understanding these 5 P’s sheds light on pharma’s intricate workings. …

In the dynamic landscape of healthcare, regulatory frameworks play a pivotal role in ensuring the safety and efficacy of medical devices. The European Medicines Agency (EMA) has been at the forefront of shaping and updating regulations to meet the evolving needs of the industry. As we enter 2024, European Medicines Agency updates in the medical device regulation promise to usher in a new era of …

The pharmaceutical research and development (R&D) realm is a fascinating and complex journey transforming groundbreaking biomedical research into life-changing medications. This odyssey involves meticulous steps, from the inception of an idea to the market release of a safe and effective drug. In this comprehensive guide, we will unravel the intricacies of the drug development and drug approval …

The pharmaceutical research and development (R&D) realm is a fascinating and complex journey transforming groundbreaking biomedical research into life-changing medications. This odyssey involves meticulous steps, from the inception of an idea to the market release of a safe and effective drug. In this comprehensive guide, we will unravel the intricacies of the drug development and drug approval …

In the ever-evolving pharmaceutical and medical device industry, success is not just about innovation and breakthroughs but also about adopting and implementing best practices. Whether involved in drug development, clinical trials, regulatory affairs, or any other aspect of this dynamic field, incorporating proven strategies can significantly impact your career growth and contribute to industry …

US FDA approval advantages for pharma companies in another country In this article, we will try to elaborate on a few tips for new pharmaceutical companies, small pharma companies, and biopharmaceutical companies in other countries to understand the advantages of US FDA approval. Also, we will discuss the importance of the FDA for their new drugs and expanding their pharmaceutical business in the …

In this article, we try to expand on “steps of New Drug Development” in general to give you an idea of the steps involved in this process and its importance. In France, six out of 90 volunteers to try a new drug went to the hospital after undergoing clinical trials, and three died of brain death. Indeed, the clinical trial of the drug has now stopped, and the drug company has called all the …