Why CMC Experts Are Crucial for Successful Drug Development
The acronym CMC stands for Chemistry, Manufacturing, and Controls and is widely used in the pharmaceutical industry and by regulatory bodies including the US FDA. The discipline of CMC includes formulation development, drug substance and drug product manufacturing, pharmaceutical analytical testing, and the overall control strategy used to ensure quality and regulatory compliance of pharmaceutical […]
CDMO vs CMO vs CRO: Key Differences
In the pharmaceutical industry, CROs refer to contract research organizations that provide clinical trial services and non-clinical toxicology services to clients. On the other hand, CMOs and CDMOs refer to Contract Manufacturing Organizations and Contract Development and Manufacturing Organizations that primarily provide drug manufacturing and drug development services. For small or mid-sized pharma companies looking […]
Top 7 Questions for Small Pharma and Pharmaceutical Startups to Ask When Choosing the Right CDMO Partner
Most pharma companies use contract development and manufacturing organizations (CDMOs) for drug development, to manufacture clinical trial material, or as part of their drug product supply chain during commercial manufacturing. But what do you need to consider when choosing the right CDMO for you? Nuance in the Details Choosing the wrong CDMO can lead to […]