Developing a new drug and getting it to a successful marketing application is a very complex and multi-dimensional process. Even focusing on a single aspect of development – chemistry, manufacturing and controls—for example, requires an understanding of many highly specialized and complicated disciplines.

Regulatory affairs personnel, working together with the development scientists, must see the “big picture” when it relates to the many individual development studies conducted. Thus, the Regulatory Affairs CMC professional must understand the issues faced in each scientific discipline and be able to evaluate the data generated with regard to its suitability for use in a regulatory submission.