February 24, 2023
Global healthcare systems require medical devices that are safe and effective in the diagnosis, treatment and prevention of diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments. However, for medical devices to be considered both safe to use and effective for […]
February 24, 2023
Drug development is an immensely complex undertaking consisting of many different, interconnected processes. Specialist regulatory affairs consultants offer services to companies operating across this challenging industry. Pharmaceutical companies and the drugs they develop must meet stringent regulations before products are approved for the market. Continue reading to learn how regulatory […]
February 10, 2023
Navigating the New Frontier of Clinical Trials! Randall Lis shares expert insights on the mandatory CTIS implementation, revolutionizing the EU clinical research landscape. Explore the key trends, benefits, and challenges shaping this transformative journey
January 7, 2023
Cell and gene therapies for treating multiple myeloma, such as CAR-T, have resulted in breakthrough health outcomes for patients. In the last decade, approval of cell and gene therapy (CGT) products has increased significantly. Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […]
January 6, 2023
Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
October 14, 2022
An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]
