Abstract
The pharmaceutical industry is continually evolving as it meets the on-going demands of external pressures such as rising development costs, patents, regulatory bodies and patients. Programmers can contribute by, accelerating the time to approval; ensuring patients receive treatment as quickly as possible. One area in particular where programmers can make a difference in accelerating the decision making, is by providing health authorities with executable code as part of the e-submission in the US. At Roche we have developed a standard approach with tools to facilitate this process.
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