July 3, 2024
Developing new pharmaceutical technologies and drugs is a complex and multifaceted process. A critical component that can determine a new drug's success or failure is the Chemistry, Manufacturing, and Controls (CMC) strategy. CMC consulting plays a pivotal role in translating a drug's target profile into an actual product by defining […]
June 13, 2024
Chemistry, manufacturing, and controls (CMC) is a critical aspect of drug development, ensuring new medications' quality, consistency, and safety. However, the lengthy approval process, which can take 10-15 years, increases expenses and limits patient access to novel therapeutics. The CMC Development and Readiness Pilot (CDRP) program aims to address this […]
May 29, 2024
By integrating Enterprise Resource Planning (ERP) systems within supply chain management (SCM), there has been a significant evolution in the operational efficiency and agility of business procedures. We aim to explore the transformative impact of supply chain ERP and see how these management systems improve efficiencies. This includes its mechanisms, […]
May 23, 2024
In this interview, NewsMedical talks to Dr. James Mencel’s Guidanceabout Scaling Up API Processes. Could you please introduce yourself and your expertise in the pharmaceutical industry? I earned a Bachelor of Science in Chemistry at Fairfield University in 1979 and a Ph.D. in Organic Chemistry at Yale University in 1984 […]
April 29, 2024
Creating a new drug involves a process that takes a lot of time and effort. When we think about drug development, it can be easy to generalize this procedure and assume that it can be approved rather quickly. However, the timeline for this approval could require you to wait between […]
April 25, 2024
The strength of the pharmaceutical industry relies on the high-quality production of medical products. All areas of the production process are important, from the beginning, when the key components and materials of medications are uncovered, to when they come together as a product and are sent to the patient. The […]
