ABSTRACT
The process for outsourcing of clinical trial supply materials can be divided into several distinct phases, and this chapter will cover both of these important elements.
The selection process to identify the right vendor Management of the contractor-client relationship to produce a
successful manufacturing outcome
Specifically, the focus of this chapter will be on outsourcing in support of pharmaceutical development work for new chemical entities (NCEs), with the emphasis on selected aspects of the chemistry, manufacturing and controls (CM&C) for drug products.
