The development phase of drug discovery is the most important and arduous. Beginning with human trial protocol development and ending with the IND/ NDA submission to the FDA, the work to be completed and managed can become a company-wide effort. Small and mid-size companies are building out infrastructure, while ranking industry is adding significantly to its marketing and sales department, which can mean workflow changes while training new employees. The volume of documents to route and manage becomes monolithic in proportion, and waiting to organize it for the NDA submission can seriously jeopardize the quality of the submission and prolong the approval process.
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If companies have not organized and managed their documents from scientific research through each phase, the workload can shut down company operations by inhibiting critical processes, such as marketing, and keeping other pipeline products from moving forward. This is the phase when companies who don't have document and process management software may begin to feel really overwhelmed. Out-of-the-box software solutions for collecting, organizing, and managing all the documents generated during the development phase can rapidly produce results, as can Change Control and Audit software.
Both MasterControl DHF JumpStart™ and MasterControl DHF JumpStart™ provide easy-to-install and implement solutions for collecting, organizing, and reviewing all the documents required to meet FDA standards.