New Drug Application—Preparation and Summarization of Modules 1-5 in Less Than 5 Months

This emerging biopharmaceutical company’s goal is to bring innovative therapies to market that provide unique and meaningful advantages to patients with renal disease as well as to their healthcare providers. Currently, this company has one product approved in Japan and two submissions in review; a Marketing Authorization Application (MAA) has been submitted to the European Medicines Agency (EMA), and a New Drug Application (NDA) is under review with the US Food and Drug Administration (FDA).

Synchrogenix® (a Certara® company), has provided this client with various clinical regulatory writing services since 2009, including clinical study reports, white papers, and presentations.

This biopharmaceutical company is a lean organization that successfully operates with a strong team of functional area Subject Matter Experts; however, they do not have an in-house writing team. As a result, when it came time to file their NDA, Synchrogenix was asked to provide a solution that would meet their aggressive timelines. What originally started as a bid to support the pivotal Phase 3 study became an end-to-end solution, including the planning, management, and generation of all documents for Common Technical Document (CTD) Modules 1 through 5, as well as document-level publishing of over 80,000 pages. Support also included the adaptation of previously completed and interim reports for studies in Taiwan and Japan.

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