Most life sciences companies are still operating with a regulatory model built for a different era.
Start with the U.S. Learn. Adjust. Then move to Europe… and eventually the rest of the world.
It sounds disciplined. It’s actually becoming a liability.
Over the past few years, I’ve watched regulatory discussions change. Teams used to focus primarily on what it would take to get a product approved in the U.S. Increasingly, the conversation is about how quickly they can bring that product to patients globally and what capabilities they’ll need to support that goal. AI-enabled authoring, digital workflows, and more coordinated regulatory engagement are becoming more frequent parts of that discussion.
Sequential Submission Is Killing Speed to Market
Global markets don’t wait anymore. While one company is learning from its first submission, another is launching in multiple markets at once, capturing patients, providers, and revenue ahead of them.
Companies should be moving toward concurrent or near-concurrent filing strategies. They should be using AI and digital tools to make those strategies more manageable. And they should be building the required ways of working into their regulatory and organizational models early, not trying to bolt them on right before submission.
I see this shift showing up in two related ways.
First, regulators themselves are creating more opportunities to work in parallel. Rolling submissions for certain FDA-designated biopharma programs, such as Breakthrough Therapy or Fast Track, allow companies to submit portions of a biologics license application (BLA) as they’re completed rather than waiting for the full dossier. In MedTech, programs such as the FDA Breakthrough Device Program and earlier, more iterative regulator engagement are encouraging companies to think less in terms of one final submission event and more in terms of a coordinated regulatory journey.
Second, companies are taking the same concept global. Shared structures such as the Common Technical Document have made it possible to build a core package once and adapt it across regions.
But building the package is only part of the challenge. Concurrent filing isn’t just a sequencing decision. It changes the work. It changes how teams author content, govern decisions, manage health authority questions, align messaging, and protect consistency across markets.
On one recent program we supported, the hardest work was not getting to submission. It was keeping up with the barrage of inquiries coming in at once, ensuring the response strategy and messaging stayed aligned, and simply meeting the expected response times.
That’s where the real capability gap shows up.
The Industry Is Solving the Wrong Problem
A lot of focus right now is on accelerating submission prep—faster authoring, faster data assembly, faster timelines to file.
Those improvements matter, but they do not solve the harder problem.
When you commit to filing with multiple health authorities simultaneously, you also need a plan for a constant stream of questions and requests from multiple health authorities. This has a high potential for overwhelming the team quickly.
FDA asks one question. The European agency asks a slightly different one. Another agency raises a related, but conflicting, concern. All at the same time. All on compressed timelines. This is where strategies unravel. Responses become inconsistent, teams get overwhelmed, and timelines slip. Not because the science isn’t sound, but because the operating model can’t keep up.
Concurrent submissions force a much bigger realization: Regulatory isn’t a downstream activity. It’s the heart of the effort.
If an organization intends to execute globally, that mindset needs to show up long before submission. It needs to influence study design, evidence generation, content planning, governance, and how teams work together throughout development.
This is the new operating model successful companies will execute.
Without Technology and AI, the Model Breaks
Most organizations can’t scale concurrent global submissions with traditional tools, processes, and ways of working. The shift is gaining momentum because technology is improving, companies are pushing for faster global market access, and health authorities are increasingly supporting more parallel and iterative regulatory approaches.
AI and digital platforms are enabling:
- Parallel authoring of submission content
- Real-time collaboration across global teams
- Consistent, traceable updates across multiple regions
In some cases, companies are cutting submission timelines dramatically. But more importantly, they’re making concurrency operationally feasible.
Technology and AI are also increasingly important because the regulatory environment is becoming increasingly complex. Cybersecurity requirements, AI governance, sustainability reporting, product traceability, and post-market expectations are adding new layers of data, coordination, and oversight.
The organizations best positioned for the future will be those that build the tools, governance, and operating models needed to manage that complexity at a global scale.
The Bottom Line
This is a strategic inflection point.
- Sequential submissions optimize for learning.
- Concurrent submissions optimize for market impact.
One minimizes risk. The other maximizes opportunity.
The companies that continue to operate sequentially will feel it through slower launches, lost market share, and increasing internal strain as complexity rises. The ones that move to global-by-design, concurrently executed strategies will define the next standard.
In my view, building the capability for a concurrent submission strategy is quickly becoming less of a competitive advantage and more of a competitive necessity.
July 14, 2026
