The Importance of Effective Communication When Working on Marketing Application Submissions

Managing, compiling, and creating a marketing application in the pharmaceutical, biotech, and medical device industries is a complex, high-stakes project. The application represents years of research and development and is a critical milestone on the path to making a new product available to the market. These applications, such as New Drug Applications (NDAs), Biologics License Applications (BLAs), or medical device 510(k) and Premarket Approval submissions, require cross-functional input, strict regulatory adherence, and include significant amounts of data and extensive documentation. In this type of effort, effective communication is essential. According to a Project Management Institute (PMI) study, poor communication is the number one reason projects fail, contributing to 56% of failures. Delayed or failed submissions can be costly, as some estimates show that life sciences companies lose millions of dollars per day if approval is delayed.

Miscommunication can stall progress, force rework, and create expensive delays that jeopardize a product’s launch window. On the other hand, consistent and transparent collaboration ensures teams resolve potential issues well before they compound, saving both time and resources. In this blog, we’ll discuss common communication challenges, best practices for issue management, and real-world examples that highlight why streamlined communication is critical to a high-quality, on-time submission.

Challenges of Effective Issue Communication

Effective issue communication requires a clear, centralized approach to managing feedback, yet many teams struggle to unify diverse channels and perspectives. In high-stakes projects, these communication gaps can quickly escalate into costly delays and errors.

Communications Across Multiple Mediums

Details can be spread across emails, calls, instant messages, and annotated PDFs, creating confusion and missing information. Without one unified system, teams often lose track of feedback or struggle with outdated drafts.

Inconsistent or Conflicting Feedback

Multiple reviewers provide separate edits, which can easily clash. Without a centralized process to consolidate comments, authors may face contradictory feedback and must corral reviewers to triage their input and develop a path forward.

Issue Buildup

Unresolved problems such as missing data or minor text errors can accumulate, leading to significant headaches just before submission. Last-minute scrambles risk introducing new mistakes or delaying final approvals.

Best Practices for Effective Issue Communication

While communication pitfalls can jeopardize a timely, high-quality submission, following a few core principles can avert most issues before they compound. By adopting these best practices, teams establish a streamlined framework that fosters transparency, resolves conflicts quickly, and keeps the entire project on track.

Unified Communication Platform

Using a single source of truth, a centralized tool where all issues, comments, and revisions are logged, ensures everyone sees the same updates in real-time and reduces duplicate or missed feedback. Minimizing resistance with transparency and real-time updates significantly decreases confusion.

Keep It Simple

Choose a platform that’s easy for all stakeholders. If it’s cumbersome, people revert to email or chat. The goal is a streamlined process where new issues are quickly logged, assigned, and resolved, all within the same space. This simplicity also helps ensure consistent usage across departments.

Separate Issue Logs from Other Trackers

Maintain one log solely for document fixes, data inconsistencies, or missing sections. Project status reports, budgeting, or timelines should reside elsewhere. This prevents crucial content edits from being buried under broader project tasks and helps teams focus on resolving submission-related problems first.

Collaboration and Version Control

Real-time editing tools that track changes can prevent overwriting or duplicative effort. In regulated industries, thorough version control is required to provide an audit trail of who changed what and when. Adopting robust version-control protocols also helps stakeholders confirm they’re always working off the latest draft

Define Expectations

Establish clear guidelines on what qualifies as an “issue.” Minor textual edits might be simple fixes, but data discrepancies could demand deeper investigation or additional approvals. Agree on categorizing and prioritizing issues upfront so everyone understands the scope of a needed revision.

Use Placeholders Strategically

Allow documents to progress even if certain data or sections aren’t finalized. Insert placeholders that clearly flag pending updates, then track and resolve them before finalization. This approach keeps the workflow moving while ensuring incomplete segments aren’t overlooked.

A Common Scenario

In many submission projects, teams encounter a familiar dilemma where final data or sections arrive late in the process. A thoughtful approach can make a big difference.

Fragmented Communication Leads to Delays

A small biotech working on its first BLA circulates documents via scattered emails. Reviewers use different file formats, and crucial edits are not tracked, so they go unnoticed. Final documents are late, causing bottlenecks in final review and publishing. Many team members skip routine meetings to align everyone toward the critical submission date. Late-stage checks reveal inconsistencies between clinical data and summary documents, forcing an extensive rewrite. The final submission is delayed by weeks, costing the company lost revenue and frustrating key stakeholders.

Streamlined Collaboration Results in a Smooth Submission

The organization standardizes on a cloud-based repository with version control. Every issue appears in a shared issue tracker. A project manager holds routine, cross-functional update meetings to track progress toward the submission date and help triage any potential issues with the entire team. Because no feedback lingers in email threads, the project manager can prioritize and assign tasks clearly and quickly. The application is submitted two days early, highlighting the power of communication and collaboration.

Conclusion

Effective communication underpins every aspect of a successful marketing application. By centralizing feedback, maintaining version control, and defining which issues require action, teams can prevent last-minute chaos and improve submission quality. Confusion and rework are minimized when these practices are followed consistently, allowing products to reach the market faster.

This disciplined approach also fosters greater collaboration and transparency, ensuring that critical decisions are not made in isolation. By removing communication barriers, organizations can reduce financial risks, achieve smoother regulatory interactions, and accelerate patient access to potentially life-saving innovations. Investing in the right tools and processes helps teams confidently navigate the complexities of marketing applications and emerge with a thorough, high-quality, and cohesive submission.