Choosing the Right Strategy: Parallel, Sequential, and Staggered Regulatory Submissions 

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.