Tips For A Smooth Marketing Application Submission

By David Shoemaker, Ph.D., Senior Vice President R&D and Rob Woolson, J.D., M.S., Chief Strategist Biostatistics and Data Standards for Regulatory Submissions, Rho

Don’t wait until late in the development process to start planning and preparing for the marketing application submission. Consider what vendors are needed and make sure they are in place well in advance. Identifying problems and gaps early in development can provide significant cost and time savings compared to problems identified during the last pivotal study.

Treat the writing, reviewing, and publishing of the marketing application as an incremental, iterative process. Sections of the marketing application can be started as early as the initial IND/CTA. For example, the information needed to complete Modules 3 and 4 is typically available well in advance of the marketing application submission. Make sure they are locked down and put to bed before the final rush, if at all possible. If the initial US IND was in eCTD format and has been kept up-to-date, substantial amounts of it may be used in the NDA. Even if it wasn’t, if a repository containing all regulatory submissions has been maintained, especially if the original source documents are available, there is a great deal of material that can be reused rather than starting from scratch. When using contract publishers and medical writers, make sure to get access to all of the deliverables produced for the initial IND and subsequent submissions to begin assembling your marketing application as soon as possible.

This article shares tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.