Key findings
Quick Answer
Claims review slows down for a handful of very specific, very fixable reasons: manual checks, sequential handoffs between Medical, Legal, and Regulatory teams, incomplete submissions, and no system to reuse what's already been approved. None of this is about reviewers not working hard enough. It's about a process that was never built to keep up with the volume of content pharma teams put out today. Review cycles in the US run 50-60 days on average, nearly one in four assets needs rework, and when a claim slips through unchecked, the FDA notices. Fixing this doesn't mean adding more people. It means catching the gap earlier.
Every marketing team has felt this moment. The content is ready. The data's solid. The launch date is set. And it's just sitting there, waiting on a reviewer to trace every single claim back to its source before anyone can say it's good to go.
This isn't a one-time thing. It happens every week, in nearly every pharma marketing team, and it rarely gets treated like the structural problem that it actually is.
What Claims Review Actually Requires
Before promotional content goes out, it has to clear Medical, Legal, and Regulatory (MLR) review. Some teams call it PRC, or technical review, depending on where you sit. The name changes. The job doesn't.
Medical checks that the science holds up. Legal checks the risk exposure. Regulatory checks it against the guidelines. Every claim in that content needs to trace back to real evidence, a study, a data sheet, a trial result.
Sounds simple. But it is this part of the process that eats the most time, and at most organizations, it's still done entirely by hand.
Where the Time Actually Goes
Delay is never just one thing. It's usually five or six things that are stacked on top of each other.
Review starts before review can start
Content arrives without its context: the reference, the intended use, the claim it's meant to support. Before a reviewer can apply any judgment, they have to reconstruct what should have come with it. One claim, one reference, one comparison. Again.
A reviewer opens the content, opens the source, and reads them side by side to confirm they say the same thing. Then they do it for the next claim, and the next. It's careful work, but it's the same mechanical comparison on repeat, and it happens before anyone gets to the questions that need an expert.
A relay where every runner waits
Medical reviews first, then Legal, then Regulatory. Nobody can begin until the person before them finishes, so an issue one function could have caught early only surfaces when the content finally reaches them.
Feedback everywhere, ownership nowhere
Comments come back in different formats, and no single person owns reconciling them. Someone ends up merging them by hand, and keeping track of which version is current becomes a job in itself.
The rework spiral
One asset can loop back through three or more partial cycles, and often a different reviewer picks it up each time. Every handover means someone new reading the content cold, so work that was already done gets partly done again.
More reviewers, more coordination, more delay
The natural fix is to add people. But every extra reviewer adds handoffs, comments to reconcile, and one more person to keep aligned, and that coordination can cancel out whatever the extra capacity was meant to give back. The bottleneck was never headcount.
Nothing gets reused
Even a claim that's already cleared review once gets re-verified from zero the next time it shows up in a new asset. Without a system built to carry that approval forward, the same work happens again, asset after asset.
A spreadsheet can tell you if a claim exists or not. It can't tell you if it's accurate. That's the real bottleneck, not a lack of effort, but a lack of a system built to check claims systematically.
Global launches now need content adapted for 20+ regulatory jurisdictions on average. That's 30% more complex than five years ago. Digital asset volume is rising 50% year over year at a lot of organizations. The work keeps growing. The process hasn't kept pace.
When the Bottleneck Isn't Caught in Time
Slow review costs time. But there's a sharper cost when a claim gets through review that shouldn't have.
FDA enforcement activity against unsupported promotional claims has increased more than tenfold in under two years. A citation existing doesn't mean a claim is accurate, a real study can still be stretched further than it proves. That's the risk sitting at the end of every one of the delays above.
Closing the Gap With Vero
None of this points to people not caring enough. It points to a process where the mechanical part of finding references, checking wording against evidence, and remembering what's already been approved still depends entirely on manual effort. Vero was built around exactly that gap, and it does it in three moves: Validate, Manage, Create.
It automatically checks every new claim against your approved references and claims library, so no one is doing that comparison by hand, one claim at a time. And it doesn't just scan for keywords and call it a match. It reads for meaning, context-aware validation that checks whether the evidence on file genuinely supports what the claim is saying. That's the difference between "a reference exists" and "the claim is true."
Along the way, it flags unsupported or misleading claims before they move any further. It checks grammar and overall content quality too, so the reviewer isn't the first person catching basic issues. And it checks alignment with brand and compliance guidelines, the kind of check that usually gets squeezed in late, if at all.
The result is review time that drops from days to minutes.
When a reviewer wants to see the receipts, they can. A claim-to-reference traceability view shows exactly which source supports which claim, no digging through a folder to confirm it. And it doesn't force every market through the same rulebook, region- or regulatory-specific rule sets mean a claim gets checked against the framework that actually applies to it.
None of these bypasses the humans who need to sign off. Configurable review workflows route each claim to the right reviewer; inside the process a team already runs. And a reporting dashboard tracks review cycle time and bottlenecks, so teams can see where things are actually slowing down, not just guess at it.
Not more people. Not a longer process. Just catching the gap earlier, every time.
FAQs
Why is claims review still mostly manual?
Because the tools most teams use, spreadsheets and email, can confirm a claim exists. They can't confirm it's accurate.
Does hiring more reviewers fix the bottleneck?
Usually not. More reviewers means more coordination, scheduling, reconciling feedback, and that overhead can cancel out any time gained.
Is the US-Europe review gap about different regulations?
No. It's more likely about process, specifically how consistently claims get checked before formal review starts, not looser standards.
Can this be fixed without changing the whole review process?
Yes. The fix isn't a new process, it's removing the manual steps inside the one that already exists. Vero does that by checking claims automatically and reusing what's already approved, rather than asking teams to work differently.
References
- Technavio, Medical, Legal, And Regulatory (MLR) Review Software Market Analysis, Size, and Forecast 2026–2030.
- Pulse Health, MLR Pharma Explained: Workflow, Stages, Common Delays.
- Pulse Health, MLR Review Process in Pharma: How Teams Reduce Bottlenecks Without Slowing Content Delivery.
- The Promo Review, What Actually Slows Down MLR Review.
- Valuebound, MLR Healthcare: How to Cut Approval Time in Half.
- Sidley Austin LLP, New U.S. FDA Letter Contradicts Decades-Old Precedent on Prescription Drug Promotion.
