From Checkpoint to Input: A Different Model for MLR

How six years of submission data shaped Klick Guardrail™ and enabled a 16-day reduction in average cycle times and 12% increase in first-round approvals, casting a light on why the gap between best and average MLR performance is so wide.

What you’ll learn:

Most pharmaceutical marketers will claim that medical, legal, and regulatory (MLR) reviews are one of the slowest steps in the commercialization process. MLR teams protect patients, defend brand integrity, and keep organizations on the right side of compliance. 

When the process works well, asset review is smooth and regulators have no concerns. But when it breaks down, even if materials emerge as compliant, revision cycles compete for production resources, timelines slip, and delays can compound across the entire commercial portfolio.

Six years of Klick submission data suggest that a significant portion of regulatory friction is not driven by the review process; rather, it is precipitated by the timing of the entry of regulatory expertise into the content development process.

This insight shaped Klick Guardrail™, a promotional review platform we built to bring regulatory and claims intelligence into content development before assets reach formal review.

What the Industry Data Show

Industry benchmarks on MLR performance are difficult to compare directly, as definitions of rejection range from final sign-off failures only to any return for changes at any stage. 

For this analysis, we define a rejection as any submission returned with required changes, including minor edits, at any stage of the formal MLR review. That conservative definition produces figures higher than industry reporting standards, but it is revealing when the objective is to speed the overall process for producing fully compliant materials.^[1]

Even with those caveats, published benchmarks offer a useful reference point for industry-average performance.

Taken together, those benchmarks reflect a common industry model in which regulatory review functions as a downstream checkpoint. Creative work is completed, content is routed to MLR reviewers, and issues are identified after the asset has already been developed.

Combining these publications in the most optimistic interpretation yields an any-stage MLR rejection rate of 26% or worse.

That model becomes harder to sustain as content volume grows. For a pharmaceutical company managing multiple brands and markets, a 26% rework rate does not stay contained to a single campaign. Revision rounds compete for production resources across brands, contingency time becomes a permanent line item in every schedule, and a 10-asset campaign at industry-average rejection rates roughly carries a 95% probability that at least one asset will require additional review.

The expansion of digital marketing has increased the variety and the operational burden of materials requiring promotional review, while review capacity has remained largely flat. The resulting pressure is becoming harder to absorb, not easier.

How Klick Approaches MLR Differently

Klick’s approach to MLR starts from a single premise: the timing of regulatory involvement matters more than the intensity of review.

Regulatory thinking enters as a creative input rather than arriving as a correction once the work is done. Our regulatory and scientific experts are part of the briefing process before creative work begins. The people who understand what claims can be substantiated, how MLR reviewers tend to respond to content in a given therapeutic category, and where the risk areas in a particular market tend to cluster are involved from the first campaign conversation. 

In practice, a medical writer and a regulatory strategist are working through what can be said and how, while a creative team is working through how to say it. By the time content reaches the formal review stage, many potential issues have already been addressed or were never created in the first place. The review functions as confirmation rather than remediation.

That process also creates a feedback loop. Across more than 40,000 reviews spanning 110 clients, 25 material types, and six years, Klick can identify patterns that would be invisible in any single account.

The aggregate outcome is an any-stage rejection rate of 12% or less. Compared with Veeva’s reported first-cycle approval rate of 74%, which implies a 26% rework rate, our approach yields roughly half the rework frequency documented in that benchmark. Across a 10-asset campaign, the probability that at least one asset is returned for additional review falls from approximately 95% to around 72%, assuming independent outcomes across assets. For a commercial organization managing dozens of simultaneous campaigns that difference is material.

How Klick Guardrail Operationalizes Upstream Review

Klick Guardrail embeds that discipline in the content development workflow. Previously approved claims, with their supporting evidence and approval conditions, are immediately available to authors as content is drafted. Teams are not relitigating language that has already cleared review, they are building on it. New claims can be checked against existing evidence before reaching a reviewer. Klick Guardrail’s Decision Intelligence applies fixed decision rules to that evaluation, providing authors with consistent guidance on how to improve their claims. For MLR reviewers, that consistency reduces the variability that drives resubmissions.

A life sciences company facing multiple simultaneous launches used Klick Guardrail to manage increasing submission volume across brands. By embedding claims evaluation into content development rather than at the review stage, the team reduced average MLR cycle time by 16 days, increased first-round approvals by 12%, and cut rework-related costs by 11%. The claims library, which previously required weeks to assemble, was built in a fraction of that time.

A Different Kind of Review

Industry-average rework rates are a process outcome, not a regulatory inevitability. They are a function of the points at which regulatory expertise enters content development and the accessibility of regulatory guidance to authors as they create content.

Klick Guardrail was built to make upstream review systematic at the portfolio scale. The result is a review process that is fundamentally faster without sacrificing accuracy.

References

About This Analysis

Data source: Klick Health Genome platform MLR submissions and timesheet records. Analysis period: August 2020 through January 2026. 6,907 projects across 25 material types; 110 pharmaceutical clients; 40,144 review submissions. Methodology uses binary approval/rejection classification; client processes vary; results represent aggregate performance across the analysis period. Full methodology documentation available to qualified researchers upon request.

Klick Health is the world’s largest independent commercialization partner for life sciences and a leading full-service pharma marketing partner, serving as agency of record for leading pharma, biotech, and healthcare brands. Klick’s specialized offerings are rooted in deep medical and scientific understanding, including market insights, award-winning creative, and proprietary AI and data models to craft impactful brand narratives and seamless customer journeys. Backed by nearly 250 medical experts and advanced healthcare analytics, Klick delivers integrated marketing strategy and communications, from new product launch strategy to MLR review with real-world evidence, helping brands thrive in today’s complex healthcare landscape. Learn more at Klick.com.