Blog | DSInpharmatics

June 13, 2024

Published by Meranda Parascandola at June 13, 2024

What CDRP Means in Chemistry, Manufacturing, and Controls

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 […]

July 3, 2024

Published by Meranda Parascandola at July 3, 2024

Can Chemistry, Manufacturing, and Controls Consulting Pave the Way for New Tech?

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 […]

July 11, 2024

Published by Meranda Parascandola at July 11, 2024

The path to perfection: A deep dive into continuous improvement in quality management

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 18, 2024

Published by Meranda Parascandola at July 18, 2024

How CMC Drug Development Differs within Veterinary Medicine

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 26, 2024

Published by Meranda Parascandola at July 26, 2024

Understanding Global Harmonization of Regulatory CMC for Animal Health

Animal health depends upon veterinary medicine. Developing new medications not only safeguards animals from various diseases and conditions, but also helps prevent the transmission of zoonotic illnesses to humans. Central to this development is regulatory CMC (Chemistry, Manufacturing, and Controls), which focuses on the composition, manufacturing practices, and quality of […]