global submission strategy

In today’s global pharmaceutical landscape, bringing a product to market often means filing marketing applications in multiple regions. Regulatory teams face strategic decisions about submissions, like choosing to file in all target markets simultaneously (parallel submissions), taking a step-by-step approach (sequential), or balancing somewhere in between (staggered). Each pathway has its own strategic and operational implications.  

At the heart of this process lies the synergy between Regulatory Strategy, Medical Writing, and Regulatory Operations. Together, they form the backbone of an efficient and compliant submission strategy, ensuring a smooth journey through the complex regulatory landscape. 

Choosing the right submission strategy depends on factors such as company objectives, regulatory strategy, resource planning, timelines, and market priorities. Each approach offers unique benefits and challenges, and the decision should align with the overall goals and capabilities of the organization. 

Parallel Submissions 

Parallel submissions are ideal when aiming for rapid market entry across multiple regions simultaneously. This approach is beneficial for products with high market demand or those addressing urgent medical needs, as it allows for concurrent review processes by different health authorities.  

However, it requires substantial resources and a well-coordinated team to manage simultaneous queries and regulatory requirements from multiple agencies. The global submission package for such submissions is strategically developed to meet the requirements of multiple health authorities simultaneously, minimizing the need for customization while maintaining compliance. 

Sequential Submissions 

Sequential submissions are suitable when there is a need to prioritize one region over others, often due to strategic market considerations or resource constraints. This method involves submitting to one health authority first, followed by subsequent submissions to other regions after receiving initial feedback.  

Sequential submissions allow for adjustments based on the outcomes of the first review, potentially improving the quality and compliance of later submissions. 

Staggered Submissions 

Staggered submissions are most advantageous when resources are limited or when there is a need to refine the submission based on feedback from initial reviews. This phased approach allows for adjustments and improvements in subsequent submissions, optimizing resource allocation and reducing the risk of overwhelming the team with simultaneous regulatory queries.  

It is particularly useful for smaller companies or those with overlapping review teams, as it provides a more manageable and strategic pathway to global market entry. 

Optimizing Global eCTD Submissions 

When planning global eCTD submissions, Sponsors must carefully weigh the benefits and drawbacks of using global submission packages. These packages can streamline the process and reduce rework by utilizing similar Modules 2–5 across submissions. However, they also limit customization for individual health authorities, potentially leading to more focused requests for information.  

To properly assess and address these complexities, Sponsors benefit from collaboration with Regulatory Strategists and Medical Writing experts to assess the impact and risks, aligning on the best strategy for their needs. Different submission approaches (e.g., staggered, sequential, and parallel) each offer unique advantages depending on timelines, resources, and regulatory requirements.  

Ultimately, factors such as company objectives, regulatory strategy, resource planning, timelines, market priorities, and global health authority interactions guide the selection of the appropriate global build strategy. A well-planned submission strategy ensures efficiency, compliance, and smooth global regulatory approvals.  

For additional details refer to the article, Success With Multi-HA Submissions. 

Collaborative Approach to Global Submission Strategy 

The MMS team brings extensive experience and expertise to the table, guiding Sponsors through the nuances of global dossier content development and assisting in choosing the best submission types. By implementing a Global Submission Strategy, the Regulatory Strategy team collaborates with Sponsors to optimize content reuse while creating the lead application and subsequent submissions. At the same time, early discussions and gap assessments help identify potential risks and streamline the eCTD writing process.  

Reinforcing the importance of cross-functional alignment, the Medical Writing team should be integrated into discussions on staggered, sequential, and parallel submissions early in the planning stage for efficient collaboration and execution of submission document development. This proactive approach ensures that the documentation is precise, clear, and compliant, reducing the number of draft reviews and streamlining development timelines. The journey of global submissions relies on collaboration. By bringing together the combined expertise of Regulatory Strategy, Medical Writing, and Regulatory Operations, MMS helps Sponsors navigate the complexities of global submissions with confidence, ensuring a seamless and successful journey from planning to approval. 

For deeper insights into MMS best practices for improving execution, aligning teams, and ensuring clarity across functions, click below to download our Executive Briefing: Best Practices in Streamlining your NDA/BLA Submission Process.  

Suggested For You

perspectives

July 22nd, 2025

Career Insights: From Military Service to Regulatory Strategy – Ritchie Patton’s Journey at MMS

regulatory intelligence

January 17th, 2025

New FDA Protocol Deviation Guidance:  Planning for the Things That Don’t Go According to Plan

news

November 8th, 2024

MMS Named a Finalist in the 2024 Fierce CRO Awards for Leadership in Regulatory Compliance

perspectives

July 16th, 2024

Key Steps to Successful CMC Authoring of IND and IMPD Submissions

perspectives

July 9th, 2024

Managing RTOR Submissions: How to Run a Successful Race from the Top Line Starting Line

perspectives

July 2nd, 2024

Part 1: RWD Noninterventional Study Design and FDA Engagement Opportunity for Early Stage Oncology

perspectives

November 2nd, 2023

Comparability Studies for Biologics: What Drug Developers Need to Succeed

perspectives

October 11th, 2023

Understanding the Revised Draft Guidance for Formal Meetings with the FDA

perspectives

August 24th, 2023

“D” is for Discipline: Everything You Need to Know About FDA's Type D Meetings

perspectives

August 2nd, 2023

Single-Arm Trials and Drug Approval in the European Union (EU)

perspectives

March 16th, 2023

New FDA Policies and Procedures for Products Submitted Under Accelerated Pathways : Understanding CDER MAPP 5015.13

perspectives

March 7th, 2023

SENDing Successful Nonclinical Submissions through Validation, Review, and Beyond