ABSTRACT
The drug development becomes increasingly competitive, international firms must internally collaborate through shared documents. Not only do documents from a single discipline increasingly require input from or review by other departments, but such documents may also be used as source, even cannibalized materials. Today's public demands safe and effective drugs to widen the armamentarium of the health practitioner. Modern society often considers access to pharmaceutical products, as part of overall health care, as a basic human right. Given the often circuitous and commensurately expensive route leading from drug discovery to marketing, opportunities for increased efficiency and international collaboration loom paramount. Discrete sections of a drug submission are often referred to as 'dossiers', especially among European agencies. All information filed with the clinical item of an NDA could be termed the 'Clinical Dossier'; other items would be similarly named. Hence, the medical writer must ensure that systems to build an Emergent Dossier will meet the needs of our customers and us.
