Is Your Complex NDA/MAA Submission Missing One of These Key Elements?

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August 21, 2018

By Martha Plaza, MBA; Amanda Truesdale, MA, MBA; and Kimberly Newton, MA. 

Together, we have more than 70 years of experience working on clinical and regulatory submission projects from several different angles. Our exposure to dozens of new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:

First, no two submission projects are the same.

Second, all submission projects can benefit from the same set of three guiding principles.

Before you launch your next submission project, consider carefully whether you’ve covered these three critical bases for a successful, punctual and high-quality regulatory application.

Integrated teams are essential.

Although the easiest way to enable truly collaborative, integrated team interaction is to use a single vendor for all key submission project functions (project management, data analysis and medical writing), there are ways you can achieve a cohesive and communicative team with multiple vendors. Key strategies include:

  • Overcommunicate. Make sure everyone is interconnected, even beyond what you may consider necessary. This helps avoid siloed communication, delays in feedback, and errors in assumption. Submission project email distribution lists can make broadcast communications a snap.
  • Use effective document-sharing systems. Online storage or file transfer options as well as sophisticated shareware editing packages can make document revisions, chain of custody tracking, group emailing and even joint live editing both simple and secure.
  • Perfect the art of the roundtable meeting. By bringing all key stakeholders to the table early in the process — and again whenever needed — your team can ensure that the various decisionmakers are present for key strategic planning, comment resolution, reviews and data analysis planning, saving time and keeping everyone informed from the get-go.
  • Assign ownership and accountability. Document Champions or matrices that designate owners and decision-makers for each document facilitate the collaborative process by ensuring someone is responsible for protecting document integrity and moving each part of the project forward. Their job is to ensure all appropriate members of the team have aligned on or approved pieces as needed before passing it through to subsequent stages. 
Creativity and flexibility are required.

It’s not a matter of whether your timeline will shift, but how and when. Be prepared to adapt using some of these key strategies for creative, flexible adjustments:

  • Build a timeline from end to beginning. Starting with the ultimate submission deadline, work your way backward to accommodate needs from every team. Don’t forget to factor in post-submission requirements, agency meetings (and possible requests for changes!), and any other non-submission deliverables (e.g. abstracts, posters/conferences, internal data presentations, etc.). 
  • Work together to find opportunities for efficiencies. When a timeline is tight, look for creative ways to work in parallel, deliver items to the next users on a rolling basis, minimize delays in feedback (see step 1), and build in advance strategies to mitigate further delays.
  • Make sure everyone is on the same page. Data analysts need to be familiar with statistical analysis plans for all elements of simultaneous submissions. Medical writers can hit the ground running with NDA/MAA modules if they have already contributed to the clinical study report or if their work focuses only on a few consistent content areas. Having large teams that work together to stay informed can ease timeline crunches and avoid inconsistency.
  • Think outside the box. Proactive planning for potential threats allows you to identify solutions in advance. Dry runs for data analysis can highlight trouble spots before final critical path analysis begins. Rolling delivery of data to medical writing can enable earlier starts on submission documents. Get creative in how you divide and conquer workload to make the submission process most efficient.
Quality is paramount.

The fastest submission project in the world is no good if its quality is sub-par. Make sure you don’t let tight timelines encroach on your performance.

  • Protect quality review time at all costs. No matter the time crunch, don’t sacrifice time required for an effective and thorough quality review. Doing so can result in more costly hold-ups for revisions down the line.
  • Plan effectively to avoid quality compromises. By being proactive about risk mitigation, key stakeholder involvement, early meetings with regulatory agencies, team integration, overcommunication, and informed team members, you can facilitate time savings that don’t just protect quality review time — they enhance it.

By bearing in mind these essential approaches for your next complex NDA or MAA submission project, we are confident you can streamline your processes and optimize performance. Each submission has its unique challenges, but the guiding elements above can ensure your team is ready to meet them.

Learn More

Read more about how to manage complex submissions — including strategies for data analysis, medical writing and project management — in our Insights Brief on the topic: “Successful Preparation Strategies for NDA/MAA Marketing Applications.”

You can also read our advice for overcoming data analysis challenges, streamlining the medical writing process, and navigating operationally complex submissions in our other blog posts.


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