Chemistry, Manufacturing and Controls for Development of Drug Substances

Provide a broad range of preclinical services required for the design, development, manufacture, and release of DS, including precursors, preliminary states, Reference Standards (RS) and all required testing. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required, even without an associated cGMP manufacturing task. These include, but are not limited to, process development and process robustness studies, development or engineering lots, and formulation studies. All activities necessary to maintain material in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions may also be required.