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Project management tips for successful MAA, NDA or BLA submission preparation

From personalised medicine to AI-powered drug discovery, the pace of pharma and biotech advancement is staggering and shows no signs of slowing down. Acquiring market approval for any new product requires effective collaboration of cross-functional teams to prepare large submissions for review by a health authority. In this article we offer project management tips to help you avoid common pitfalls and to prepare your submission with confidence.

Preparing submissions is a collaborative effort between a team of subject matter experts (SMEs). Those involved in the preparation of a marketing authorisation (MAA), new drug application (NDA), or biologics license application (BLA) represent specialties such as Clinical Medicine, Clinical Operations, Pharmacology, Biostatistics, Chemistry, Manufacturing and Controls (CMC), Data Management, Non-Clinical (including Toxicology), Pharmacovigilance, Regulatory Strategy, Regulatory Publishing, Regulatory Project Management, Medical Writing, Medical Affairs, Commercial and Legal. Depending on the product there may be even more SMEs from other areas involved.

“Submission preparation is a marathon, not a sprint—but that doesn’t mean it has to be chaotic. With the right structure and smart collaboration, your team won’t just survive submission season—you’ll conquer it.”

— Erika Ghiggeri, Snr Manager, Project Services, ICON
 

Coordinating the combined efforts of so many individuals and departments requires oversight from a skilled project manager. A regulatory project manager (RPM) is the linchpin in the submissions process, influencing how SMEs collaborate to prepare the dozens of required documents. ICON RPMs, who work with a wide range of sponsors, have built up a robust collection of lessons learned. 

Key messages: The anchor of consistency

A key messages document is a high-level summary of data that ensures consistency across the submission. Sponsors are strongly encouraged to create one as a central point of reference for the multiple submissions’ contributors. This document is especially helpful to medical writers drafting clinical study reports (CSRs) and Module 2 summaries. Each point should be a concise, approved statement that can be copied directly into MAA/NDA/BLA documents. Because these messages have already been vetted, reviewers can trust the wording, freeing up their time to focus on sections still under development.

In addition to overarching themes, the key messages document should define how the product is referred to throughout the submission. With many contributors, consistency can easily get lost in hyphens, capitalisation and phrasing.

Other details to include:

  • Primary and secondary endpoints from pivotal studies
  • Definition of efficacy
  • Drug product description
  • Dose regimen and rationale
  • Clinical trial participant population
  • Proposed proprietary name
  • Descriptions of supportive clinical studies

Consider using a tabular format to align each message with supporting tables, listings, and figures (TLFs) and commentary.

You can begin drafting the key messages document before last subject out (LSO) using:

  • The target product profile (TPP)
  • Health authority feedback
  • Clinical study reports
  • Published literature

After updating it with topline data, the document should remain in a steady state, enabling medical writers to lift exact verbiage into Module 2 summaries.

Clinical document shells: The scaffolding before the data arrives

Once the key messages are established, medical writers can begin drafting document shells—non-data-dependent portions of documents like CSRs, 2.7.3, 2.7.4, ISS, ISE, and 2.5. Creating shells early helps the team demonstrate progress pre-LSO and ensures cross-functional review time for data-dependent sections is used efficiently.

Reviewers’ matrix: Who's in, who's out and who has the final say?

Typically formatted in Excel, the reviewers’ matrix maps out SMEs, their departments, and their review responsibilities. It should also clearly distinguish between reviewers and final approvers.

If the sponsor has standard operating procedures (SOPs) dictating review involvement, populating the matrix is relatively straightforward. If not, the RPM should coordinate with functional leads to identify SMEs.

This step often takes longer than expected. Consultants may join late or be absent from early rosters, so don’t rely solely on kick-off meeting lists. Indicate who is reviewing which drafts (e.g., “D1,” “D2”), and use “V” to denote visibility for SMEs who aren’t reviewers but should stay informed. 

Often, more than one individual from a single department will be involved in document review. In these cases, we recommend that internal alignment take place before the comment resolution meeting (CRM). Departments should consolidate their feedback and designate a single representative to attend the CRM on their behalf. This helps prevent contradictory comments from the same function and provides a clearer path forward for the medical writer. To further streamline the process, the Reviewer Matrix should indicate the departmental lead, giving the medical writer a consistent point of contact for resolving questions and incorporating edits.

The matrix should be finalised before document development begins.

Quality Assurance/Quality Control: Clarity beats chaos

RPMs should facilitate early and clear communication between Clinical Operations and Quality Assurance (QA) and Quality Control (QC) teams. Document authors must receive QA/QC checklists well in advance—ideally at the kick-off meeting. For example, sharing the QA checklist for a CSR with the medical writer during early drafting can reduce findings later. These checklists help contextualise auditor expectations and strengthen document quality from the start.

Publishing: Do it early and often

The RPM and regulatory publisher should align early on:

  • Publishing timelines by document type (for example, summary documents vs. study reports)
  • The handoff process (via content plans, dashboards, and so on)
  • Final output review: who is responsible and how it will be conducted

Clarify all of this at the kick-off meeting or shortly afterwards.

Release documents to publishing on a rolling basis to allow time to address technical issues (bookmarks, hyperlinks, tables of contents) and ensure the document is submission ready.

Effective document review: Say what matters

Verbiage from key messages or protocols should be adopted without modification. Authors should flag such sections to discourage reviewers from altering vetted content. Encourage SMEs to focus on content, not style. Wordsmithing is tempting, but medical writers should ensure the writing meets grammar, flow and style standards.

All reviewer comments must be clear, actionable, and directed to the appropriate SME. Avoid vague feedback like “?” or “needs clarity.” Instead, suggest alternative phrasing or specify what is unclear.

Ad hoc tables: Plan the unexpected

When drafting integrated summary of efficacy (ISE) or integrated summary of safety (ISS) components, teams often request ad hoc tables. These can delay timelines depending on their complexity and available resources. To prevent bottlenecks, discuss potential TLFs early in the submission planning process and finalise inclusion well before drafting begins.

Sequestering: Proximity doesn’t guarantee productivity

Major submissions are high stakes for sponsors, shareholders and most importantly, clinical trial participants. As a result of this, leadership often adopts an “all hands-on deck” mindset. SMEs may be told to prioritise submission work over other responsibilities. Sometimes teams are asked to assemble in person for a week or two to draft key clinical summaries for Module 2 (particularly sections 2.7.3, 2.7.4 and 2.5).

Sponsors should weigh the pros and cons of this approach carefully before committing to it. Considerations include:

  • What are the logistical and financial costs of bringing SMEs together in one location?
  • Can these contributors be excused from their other obligations?
  • Will in-person attendance ensure their full focus, or will distractions persist despite the setting?
  • How will this approach impact the medical writers? Often, they are expected to work late to incorporate a day’s collaborative edits into the version for review the following day

While the intent behind sequestering is to foster focus and alignment, it can also create undue strain, particularly for writers facing unrealistic turnaround expectations. Like any high-pressure tactic, it should be applied with care, clear planning, and realism.

Conclusion

Submissions don’t succeed by accident—they succeed by alignment. With strategy, structure, and smart execution, a dossier is not merely a collection of various documents. Rather, it is a story outlining the development, safety and efficacy of a potential lifesaving or life-improving medical advancement. Position your team to share your product’s story with clarity, confidence, and purpose.

Learn more about ICON’s Regulatory Project Management services, or reach out directly.

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