Biopharmaceutical companies have set bold ambitions to reduce regulatory-submission timelines for new products. This is part of broader efforts and ambitions over the past decade to compress clinical timelines and revitalize stagnant R&D productivity in the industry. Among the many steps required to deliver new medicines to patients, the often-time-consuming submission process presents an exceptional opportunity to accelerate the drug development period.
Faster and higher-quality submissions during drug development can provide substantial benefits to patients, pharma companies, and other stakeholders. For example, it would provide patients with earlier access to potentially life-saving therapies. Additionally, per our analysis, a pharma company making an improved submission for a $1 billion asset one month more quickly than typical would unlock roughly $60 million in net present value (NPV).
In the past five years alone, the pharma industry has made impressive progress in reducing filing timelines. Per McKinsey’s benchmarking data, some leading companies have accelerated their overall submissions by up to three times over the 2020 industry average, and others are now sustainably delivering filings eight to 12 weeks after database lock (DBL), cutting historical timelines by 50 to 65 percent (Exhibit 1). Our estimates show that companies that achieve this feat could extend patent exclusivity during peak revenue years and, in doing so, obtain roughly $180 million in NPV for a $1 billion peak sales asset.1
Almost all top pharma companies have set ambitious filing timeline targets—the most ambitious are aiming to file in fewer than eight weeks. Yet many companies struggle to transform their submission processes at scale. Key obstacles include the complexity of digital integration, diverse therapeutic modalities, and internal capability gaps, all of which have led to inconsistent execution across the industry.
We propose a path forward that draws from our work with several top 20 global pharma companies. This article describes the six building blocks of successful submission excellence transformations—approaches that consistently produce high-quality submissions. It also explores technologies that can enable faster submission, including automation and gen AI, and offers three implementation approaches for companies to revamp their submission journey.
Six building blocks of submission excellence
The six elements of successful submissions span three core areas: strategic and process foundations (simplified filing strategy and redesigned zero-based process), organizational transformation (radically changed operating model), and technology enablement (modernized core systems, scaled task automation, and scaled, AI-enabled content generation). Together, they create a comprehensive approach to achieving sustainable submission transformation (Exhibit 2). Although companies may choose to implement the six building blocks in varying combinations and sequences, the most successful transformations pursue all of them.
Block one: Simplification of filing strategy
Organizations should start with a filing strategy that’s built on rigorously defining and targeting the desired product label. This approach promotes collaboration across different teams, such as biostatistics, clinical-development, marketing, regulatory, and safety groups. As a result, the study designs meet all requirements while focusing on critical-path activities. Clinical programs designed by regulatory strategists with a laser focus on efficiently demonstrating a product’s benefit and risk profiles can be combined with proactive education and engagement from health authorities.
Block two: Zero-based redesign of submission process
Several top pharma companies have taken steps to fundamentally redesign their entire submission process, starting with the last patient’s last visit and extending all the way to filing. Some have taken a gradual approach by applying lean principles to improve each step. Others have achieved faster results by conducting a zero-based redesign of core processes and automating key aspects of their operations. They have employed such strategies as bold decision-making, front-loading, “parallelizing,” and removing nonessential dossier activities (table).
Pharma companies can accelerate submissions by optimizing processes across seven categories.
| Category | Examples | ||
| Data preparation optimization |
| ||
| Predrafting of lean clinical reports and chemistry, manufacturing, and control reports, with hyperfocus on label |
| ||
| Batch generation and tables, listings, and figures (TLF) standardization |
| ||
| Strategic review in 24 hours, with a single round after DBL |
| ||
| Submission publication around the clock |
| ||
| Clinical-pharmacology-process optimization |
| ||
| Automation |
|
Redesigning core processes can alleviate the substantial workload placed on global regulatory teams caused by inefficiencies in responding to health authority queries (HAQs). These inefficiencies can slow the correspondence between pharma and health authorities and, by extension, the resolution of HAQs. This problem is magnified when companies file submissions simultaneously in multiple countries to reach a larger patient population faster.
Block three: Radical change of core operating model
A successful process redesign requires a fit-for-purpose operating model that aims to deliver faster, more sustainable submissions. As such, organizations should embrace a paradigm shift in their submission process and be prepared to acquire the capabilities needed to scale the adoption of new processes. Lasting success depends on adequate training, focused capability building, strong leadership commitment, and clear expectations across the product portfolio.
Pharma leaders should target these important outcomes for their operating-model overhauls:
- Autonomous, small cross-functional teams. The teams should include biostatistics, regulatory, and medical-writing groups and be empowered with clear goals and incentives to work in sync.
- Rigorous planning and sustainable execution of the filing process. A submission manager leading the team needs to initiate early filing preparations, have full accountability for the critical paths, and ensure that no detail gets overlooked.
- Faster, focused decision-making. Leaders should be able to make bold, early decisions on high-value assets.
- Culture of bold innovation and collaboration. Team members should be encouraged to push boundaries within and beyond their functional roles.
- Stronger vendor partnerships. There needs to be real-time collaboration with external vendors to provide seamless execution and prevent last-minute delays.
Block four: Modernization of core technology for digitization and automation
Technology is critical in sustainably accelerating regulatory submissions. Modern, integrated core systems, such as regulatory-information-management systems (RIMS), enable seamless workflows, embedded automation, and data-centric approaches that replace document-heavy processes. According to data from McKinsey’s 2025 regulatory affairs benchmark, roughly 80 percent of top pharma companies said that they were modernizing their RIMS. Some had automated core processes beyond basic writing tools, quality controls, and publishing by applying structured content and collaborative authoring within a data-centric submission workflow (Exhibit 3).
Leading pharma companies are investing in scaled workflow automation and digital data flow, integrating technology from protocol development to submission. Their biggest challenges are navigating the complexity of available solutions, prioritizing high-impact investments, and building internal capabilities to adopt and scale automation. Some industry leaders are laying the groundwork for real-time data updates and automated exchanges with health authorities, thanks to the emergence of next-gen RIMS platforms and external initiatives that have focused on building technology bridges between sponsors and regulators. The widespread adoption of this workflow is still to be fully realized. To achieve the full potential of a data-driven regulatory future, companies should develop a clear strategy, scalable technology road map, and structured implementation plan.
Block five: Scaling of automation for manual tasks
Automation promises to be a game changer for the submission process, yet it remains largely underused beyond core tasks, such as dossier writing and validation (Exhibit 4). For example, internal benchmarking reveals that only 13 percent of companies automate the time-consuming formatting of tables, listings, and figures at scale. Likewise, the global workflow associated with the HAQ process—a major contributor to the workload—remains largely unautomated. The opportunity exists for organizations that successfully scale automation in these areas to make considerable gains in filing speed and workload efficiency.
Block six: Scaling of gen AI for content generation
Gen AI is emerging as a major disruptor in regulatory and medical writing. Early pilots show that gen-AI-assisted medical writing can help reduce the end-to-end cycling time for authoring of clinical-study reports (CSRs) by 40 percent.2 And more recently, McKinsey and Merck codeveloped an AI-powered platform that reduced first-draft CSR writing time to 80 hours, from 180 hours, and cut errors by 50 percent.3 Many companies are now expanding into other regulatory document types, including safety and efficacy summaries, labeling, and even clinical pharmacology, to enable further submission timeline compression. Gen AI could also be used to generate HAQ responses, which could streamline that time-consuming task, including for situations when multiple health authorities submit queries simultaneously. Also, we’re observing meaningful advances with agentic AI, which could be used as a virtual content challenger alongside a human in the loop who reviews the submissions to anticipate lines of questioning and improve the overall quality of a dossier during the internal review and quality control process.
Leading companies are already developing technology plans and building AI-ready capabilities to stay ahead in this transformation. To overcome scaling challenges and capture gen AI’s full benefits across entire pipelines, leaders should prioritize four actions:
- Modernize core clinical-data systems to support AI-driven automation.
- Build state-of-the-art gen AI authoring platforms with reusable components that balance flexibility and precision for high-stakes documents.
- Invest in AI adoption with well-defined workflows that secure compliance and high quality.
- Upskill talent, including by training employees in the effective use of these tools and broader AI adoption strategies.
Submission transformation over three horizons
Although companies choose to take their own approach to accelerating filing, we have observed that successful submission transformations follow a sequence across three discrete horizons (Exhibit 5). Within each horizon, companies typically choose one to three high-priority assets to hasten through the filing process while they adjust their underlying processes for sustainability. This strategy can yield early, tangible benefits to top-line revenue and resource capacity while systematically addressing fundamental governance, processes, systems, and ways of working.
Horizon one: Revamp the operating model and processes:
- Using building blocks two and three, this horizon primarily involves the execution of a zero-based redesign of the submission process and radical changes in the core operating model.
- Examples of outcomes include more flexible governance, improved execution rigor, and basic technology improvements, such as workflow automation.
- The DBL-to-filing timing is approximately 12 to 14 weeks.
Horizon two: Perform a zero-based redesign of the operating model and experimentation with emerging technology:
- Using building blocks one through five, this horizon involves the execution of a laser-focused filing strategy and a full revamp of the operating model and processes, including a zero-based design of all core processes and entirely new ways of working.
- Examples of outcomes include automation integration for structured content authoring, source updates, and translations and the use of gen AI for generating content, such as clinical-study reports.
- The DBL-to-filing timing is approximately eight to ten weeks.
Horizon three: Shift the paradigm from scaling technology to submission:
- Using building blocks one through six, this horizon involves a full embrace of all the submission transformation elements, including scaling new technology, such as gen AI, and adopting a human-in-the-loop operating model.
- Examples of outcomes include achieving filing speeds in fewer than six weeks and positioning the organization for such radical changes as fully paperless filings and real-time data sharing with health authorities. A precursor to the latter innovation is the US Food and Drug Administration’s real-time oncology review, which aims to accelerate access to safe, effective cancer treatments through streamlined reviews and early communication with applicants.
- The DBL-to-filing time is fewer than six weeks.
Leading pharma R&D companies are prioritizing faster clinical development and shorter regulatory-filing timelines to capture massive value for their stakeholders. While such companies have made impressive progress, others could achieve ambitious timeline reductions by achieving submission excellence and upgrading their core technology. Leaders of regulatory-affairs teams should make informed decisions, develop winning technology plans, and equip teams with game-changing capabilities. Done correctly, an improved regulatory-filing process could play an outsize role in accelerating the delivery of life-saving medicines to the patients who need them most.
