July 18, 2024
The costs of developing a new medication can amount to over $1 billion, depending on the complexity of the drug and expenses associated with unsuccessful studies. With these costs in mind, an optimized regulatory process is required to ensure that the procedures behind drug development are secure, safety-oriented, and reliable. […]
July 11, 2024
What principle does DSI prioritize for continuous improvement for quality management? How do these principles contribute to the advancement of quality management systems? Continuous improvement is an industry expectation. If you are using quality management systems on a daily basis, it is important to keep up with changes and trends […]
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 […]
