Meranda Parascandola
May 13, 2023
Identifying critical process parameters (CPPs) is essential for ensuring the quality, safety and efficacy of pharmaceutical products. Critical process parameters are the key input variables that can affect the quality and consistency of a product. Failure to appropriately control these parameters can result in production failures, batch rejections and product […]
May 4, 2023
Diagnosing illnesses and monitoring health is increasingly reliant on utilizing software. For patients, manufacturers must maintain standards and regulations. Companies can be concerned with challenges concerning updated legislation such as the EU’s MDR. Companies have increased importance on determining whether their software is categorized as a medical device, as well […]
February 27, 2023
When pharmaceutical companies develop a new drug product for the market, there are many different steps a potential product must go through to determine and control its safety, manufacturability, effectiveness and reliability. These processes, and all activities within, are known as chemistry, manufacturing, and controls (CMC). CMC is done during […]
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 […]
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 […]