The Regulatory Affairs department is an important part of the organizational structure. Internally it liaises at the intersection of drug development, manufacturing, and marketing. Externally it is the key interface between the company and the FDA.
The Regulatory team is involved in the development of new products from early on, by integrating regulatory principles. In addition, by preparing and submitting the relevant regulatory dossiers to FDA, Regulatory ensures the information and data to be conveyed and discussed with FDA are presented in the right way and correct form.
Regulatory Affairs contributes, essentially, to the overall success of drug development, both at pre-marketing stages and post-marketing. Since the regulatory environment is constantly changing the regulatory team provides advice on necessary updates to the appropriate disciplines in the organization.