As your company moves towards the regulatory submission of a marketing application to a health authority, there are many things to consider in your project planning. Among those is whom your key vendors will be. It’s already challenging enough to figure out which vendors you should be engaging, and it’s even more challenging to know when to engage each of them. One example of this is in electronic Common Technical Document (eCTD) publishing.
At first glance, you might think that choosing an eCTD publishing vendor can wait until near the end of your project timeline. After all, you can’t start publishing the submission until all the regulatory content has been generated and finalized, right? Wrong. Don’t wait until it’s too late. Here are three reasons why the earlier you engage an eCTD vendor, the better off you’ll be.
Consider your team’s bandwidth
Consider is how thinly stretched your team will be as the target submission date grows closer. On the sponsor side, your team will be engaged in writing, reviewing, or managing the authoring of many key components of the submission. You may also be involved in things like coordinating the closeout of your pivotal clinical study, managing contract research organizations, data management, and biostatistics vendors, or solving a lingering Chemistry, Manufacturing and Controls (CMC) issue. On top of all of that, you’ll also be responsible for reviewing and approving the eCTD publishing work. Leaving the selection of an eCTD publishing vendor and its work until the end of the project will further magnify the stress you’re under.
Many files are finalized sooner
A typical marketing application includes hundreds of thousands of pages of regulatory documents across more than a thousand individual files and can climb into the millions of pages if a significant number of large case report forms are included. While some key documents will not be finalized until the end of the project (Module 2 summaries, for example), most files to be included in the submission are usually finalized sooner, and some of them are likely available for publishing now (such as nonclinical study reports).
Take advantage of the experience
Engaging an eCTD publishing vendor earlier in the project allows the vendor team to become part of your overall project team. Those team members have been through this process many times before and have a wealth of experience that will benefit you. They can recommend authoring templates to facilitate the creation of submission-ready documents. They can provide insights on how to organize your documents to facilitate easier post-approval updates. They can advise on how to structure the content within your documents to make them more navigable and “reviewer friendly.” They can even help you plan how to efficiently submit the same application to multiple regulatory health authorities (FDA, EMA, PMDA, etc). Most importantly, a good eCTD publishing vendor can help you to identify and avoid common pitfalls, which can jeopardize your submission timeline and put your overall success at risk.
How far in advance should you engage an eCTD vendor?
So, when is the best time to engage an eCTD publishing vendor? For a marketing application, we recommend that you begin seeking an eCTD vendor 12-18 months in advance of your target submission date, with the goal of having your chosen vendor on board no later than 9-12 months in advance of your target submission date, erring on the high side for larger submissions. This timing allows for eCTD publishing to proceed at a steady pace, publishing documents as they are completed and avoiding a large bolus of work at the end of the project that could threaten the submission success.
For customized submission support that accelerates and anticipates, consider Certara Synchrogenix. Learn more about our regulatory operations and eCTD publishing services.
