Datasheet | January 27, 2009

Datasheet: Regulatory Strategy/Submissions Services

Source: Aptuit, Inc.

Regulatory Affairs is a key area of pharmaceutical consulting which touches all other disciplines (eg, chemistry, manufacturing, and controls; preclinical; and clinical). Knowledgeable in the FDA, HPFB, and EMEA regulatory requirements for clinical testing and marketing approval and serving as a conduit to regulatory authorities, Aptuit Consulting provides a cohesiveness to the drug development continuum that is critical to achieving approvable drug submissions.