Chemistry Manufacturing Controls Consulting Services

Chemistry Manufacturing Controls

The new medicine must be made before it can be tested in vitro and in animals. It must then be scaled up, so that it can be administered in toxicology studies, in clinical trials, and then after the drug is approved for commercialization. The process of manufacturing, testing and controlling the drug is called Chemistry Manufacturing Controls. Specialized skills are needed to become an expert in Chemistry Manufacturing Controls. Pharmacists are uniquely placed to have these skills. They understand how drug substances are manufactured and controlled, as well as how drug products are manufactured and controlled. Speid & Associates are experts in Chemistry Manufacturing Controls Consulting, including:

  • Selection of manufacturers for small molecules
  • Selection of services that can test for stability
Development of the strategy for terminal sterilization
Development of the strategy for aseptic processing
  • Selection of manufacturers and other services for biologics
  • Selection of one stop shop for all CMC processes for drug substance and drug product

    Chemistry Manufacturing Controls Expert

    The expert in Chemistry Manufacturing Controls Consulting is an important part of the drug development team, and is worth everything they are paid. Failure to hire such a person is likely to result in the program being placed on clinical hold.

    The Chemistry Manufacturing Controls Expert will help with the following challenges:

    • Development of the CMC strategy
    • Development of the impurity strategy
    • Development of the Drug Substance and Drug Product strategy\
    • Creation of the product labeling for the new medicine