Marketing Application Publishing Best Practices

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. While the publishing journey can vary depending on your therapy’s requirements, Veristat’s regulatory publishing experts have shared some common best practices as you prepare to publish that provide a helpful path to submission.

1. Schedule a kick off meeting sooner rather than later

A publishing-specific kick-off meeting should happen at least a year out from the target submission date. At Veristat, our publishing team suggests that all key stakeholders from clinical, CMC and relevant non-clinical functions be involved. On the agenda: review overall timelines, understand when to expect rolling receipt of documents, and discuss the overall delivery process. During the meeting, important milestone targets for document delivery will be highlighted for which we— and our sponsor— should align.

Another important aspect of the kick off meeting is to ensure a basic understanding by all involved of the entire publishing process along with the steps that go in to making documents “submission ready”. Document level pre-publishing, eCTD or electronic publishing, QC processes, and final review and validation leading up to submission should be reviewed. We find that explaining these processes early on helps our sponsor’s team better understand how our timelines are developed and encourages all to stay on course. We believe it is our job to provide a realistic expectation of how much time the process is going to require. This helps our sponsor manage expectations as to when and how activities move forward.

2. Facilitate ongoing communication

Effective communication is an integral aspect of effective publishing management and the backbone of a successful submission. To facilitate responsive and relevant communication, our publishing experts recommend that reviewers with decision-making authority be identified early on. One single point of contact who serves as the day-to-day interface with Veristat’s publishing lead makes for the ideal collaboration. If that isn’t feasible, a point of contact for each module is certainly acceptable.

Regularly scheduled meetings help projects stay on track. The meetings may start off less frequently as the program kicks off and then increase to weekly or bi-weekly as we get closer to submission. We advise that our primary sponsor contact attend all publishing meetings and update the team on the status of the various aspects of the marketing application. For each meeting, Veristat’s publishing lead will provide a populated table of contents tracker for each module. Publishers rely on this tracker to build the submission. It serves as an important tool to ensure that the content aligns with our sponsor’s status and their expectations.

Once the content for each module is defined, we use our meetings to track timelines for final documents and make updates for any content changes. This allows us to identify late-breaking components and plan accordingly, as many documents are “linked” together and a delay in one can have a trickle-down effect on the others, especially if external hyperlinks are needed.To illustrate the intense nature of work associated with hyperlinking and why advance planning is essential, a recent NDA submission came in at a whopping 8.3GB, containing approximately 2,700 files. The module 2 sections alone contained roughly 1500 hyperlinks, all of which needed to be created and QC’d by our publishing team.

3. Prepare for unexpected program delays

No matter how much we plan for and anticipate an ideal flow of activities, it is important to acknowledge that things will change along the way. It is impossible to predict the future. However, our publishing experts have identified some ways to alleviate some of the challenges that delays can have on the submission schedule:

Scenario #1: Veristat’s publishing lead receives final documents, completes the publishing and QC processes, and the final documents are later updated by our sponsor. When this occurs, we review the updates with our sponsor and work to replace only those individual pages that contain modifications instead of replacing the entire document. This allows our team to save time with QC and preserve most external hyperlinks. While this approach may not always be feasible as it is dependent on the extent of the updates, it is a tremendous time-saver for sponsors when it can be implemented.

Scenario #2: specific documents contained in the eCTD are running late due to challenges taking place on our sponsor’s side. In this situation, our publishing experts will add in placeholders to the file for those documents that we know will be provided later. This allows us to create the necessary external hyperlinks and, once the final version is received, we are then able to replace the placeholder document so that all external hyperlinks stay intact. 

Scenario #3: our sponsor alerts us that previously submitted documents have been located and are accessible and available. This update is one of the more positive aspects of expecting the unexpected. Our publishing experts view previously submitted documents as a fairly simple way to help reduce time delays. The documents have been already formatted and pre-published to guidance specifications. They can be provided to Veristat by the sponsor’s third-party publisher, if applicable, or by sourcing them from the actual agency submissions. This can certainly save time with pre-publishing and QC.

Lastly, when we are notified of the need to incorporate late-breaking documents, we can quickly add expert publishing, regulatory, and biometrics resources to our team to ensure the final submission stays on track. Communication is key throughout the marketing application process! 

Additional Considerations to Bear in Mind

To learn additional best practices on how to map out a publishing timeline, plan the sequence of which module to complete and when, and more, listen to our podcast on Marketing Applications Best Practices for Publishing here.

By implementing our proven publishing strategies, you’ll be well on your way to a successful marketing application submission. 

Veristat has a wealth of experience in regulatory publishing and in all facets of clinical regulations. Our experts can help you develop a detailed strategic plan tailored to your product that will reduce your regulatory risk. Listen to all of our episodes in our regulatory podcast series here. You can also subscribe to ART Podcasts on your favorite podcast player.