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No two new drug applications (NDAs) or marketing authorization applications (MAAs) are the same. Learn the key strategies that can be implemented to propel even the most complex submissions to successful regulatory conclusions.
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A mid-size pharmaceutical company and its development partner, a small biotechnology company, engaged Veristat to complete the medical writing for their product’s MAA, NDA, and NDS. Learn how our medical writing team worked closely with the sponsors to write these marketing applications in an accelerated timeline.
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A pre-commercial biopharmaceutical company came to Veristat for consulting services following a rejection by the FDA of their application for a special protocol assessment (SPA). Learn how Veristat transformed the clinical trial design and the statistical foundation of the SPA, which helped it achieve regulatory agreement.
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Explore how effectively managing the publishing of documents required for a marketing application submission can help accelerate the time it takes to bring your product to market. Yet, the publishing process can be complex and daunting. It's quite easy to waste valuable time if you don't have a plan in place to work against and keep you on track.
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In this webinar experts explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and coordinate with the medical writing team so that all the information needed to write and complete the modules of the submission is provided with adequate time for review and quality control.
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