ABSTRACT
This chapter discusses the document development and associated technologies that support global teamwork, based on the work within the pharma industry. The processes of document development and teamwork described above are idealized, representing how the process unfolds with the teams and leaders most willing to change traditional practice. Drug products reach the market by successfully negotiating health authority gatekeepers and by having well substantiated claims for new or more effective disease treatment. The New Drug Application is the major document set that presents the case for approval to authorities. The pharma development process delivers drugs from the research lab to the market. The process is notoriously long—some twelve years on average from discovery or recognition of a new drug substance to marketing a drug product. The successful filing of an NDA is threatened by inconsistent claims, poorly coordinated presentation, or confusing organization.
