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. If companies have not organized and managed 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. 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.
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Biotechnical Development Phase Software Solutions
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Controlled Documents Managed in the pharmaceutical Development Phase | Collaboration Workflows in the Biotechnical Development Phase | |
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The volume of documents to route and manage can become overwhelming during the development phase if companies wait to organize it for the NDA submission. MasterControl provides two out-of-the-box solutions for helping companies collect, organize, and manage all documents necessary to satisfy FDA submissions requirements.
For more information about biotechnical development phase, feel free to contact MasterControl representative.
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