Most people in pharma have at least heard of the MLR process, if not played a part in it. But even seasoned pharma professionals will admit that the MLR process is incredibly complex, partly because of the sheer number of key players involved. Each plays their own important role and is reviewing for different reasons. In our second installment of our new blog series, Role Call, we’re exploring the role each reviewer has in helping create and approve promotional materials—and how technology can help.

Like an orchestra working together to create beautiful music, the Medical, Legal, and Regulatory (MLR) review process requires discipline, attention to detail, and teamwork. Together, the MLR review team ensures pharmaceutical content is accurate, truthful, compliant, and balanced. 

In our last article, we explored the role that Medical Reviewers have in the process—evaluating the scientific and clinical accuracy of all claims that are made. Today, we’ll take a deep dive into the important role the Regulatory Reviewer plays in MLR reviews. 

The Regulatory Reviewer’s job

The Regulatory Reviewer’s primary responsibility is ensuring that promotional materials are compliant with everything from 21 CFR Part 202, to FDA guidance documents, to approved labeling. Above and beyond checking compliance with governing bodies like the FDA, EMA, or MHRA, they’re often tasked with interpreting evolving regulations across multiple jurisdictions and helping their promotional materials and approach adapt to shifts in the regulatory environment. 

While their fluency in existing and emerging documentation is paramount, their ability to interpret risk and make judgement calls based on their expertise is another key skillset. 

The Regulatory Reviewer’s biggest challenges 

As a Regulatory Reviewer, the task list is long. Here are some of the key challenges people in this role face: 

• The sheer volume of regulations and guidance is massive. Regulatory Reviewers must be fluent in a wide range of guidelines, not only in the United States but often in a global capacity. 

• Guidance is always changing. As new drugs, treatments, and technologies come to market, regulations are always evolving to meet the changing landscape. And, there are often multiple interpretations on one piece of guidance. 

• Reviewing contextually is a challenge. In addition to reviewing the content itself, Regulatory Reviewers must consider how claims are presented, including small details like font size.

• The stakes are high. The accuracy of claims has a significant impact on patient safety, as misleading claims can lead to inappropriate prescribing decisions. There’s also a financial and brand reputation risk from regulatory violations. Life sciences companies have paid over $50 billion in fines over the past 25 years. 

How AI can help Regulatory Reviewers

AI technologies can act as a second set of eyes for busy Regulatory Reviewers. AI can monitor changes in regulations, then provide a summary of changes, as often as necessary. It can also save time by automating the checking of content against certain regulatory codes. And, as more pharma companies are taking a modular approach to the creation of promotional materials—assembling blocks of pre-approved content for various audiences, channels, and markets—AI can keep track of the various configurations and approval status. When regulatory changes occur or new guidance is issued, AI can identify which modular content blocks need updates and, through complete traceability, determine the downstream impact on all assembled promotional materials that use those modules. This prevents compliance gaps and ensures that regulatory changes are systematically addressed across all affected content.

AI can also accelerate the fundamental work of compliance checking by automatically comparing promotional claims against approved labeling, relevant FDA 21 CFR regulations, and guidance documents. This automated screening allows Regulatory Reviewers to focus their expertise on nuanced interpretation and risk assessment rather than routine compliance verification.

How Revisto support Regulatory Reviewers

Applying the power of AI to the time-consuming MLR review process, Revisto integrates directly with Veeva Vault PromoMats and streamlines the review process for the entire team, without sacrificing quality or compliance. 

For Regulatory Reviewers specifically, Revisto automates regulatory requirement detection, checking against relevant FDA 21 CFR regulations and guidance documents, automatically flagging any violations. The platform understands the applicable regulations for each specific product, ensuring that content is evaluated against the correct regulatory framework based on indication, therapeutic area, and market requirements. 

Revisto learns each company's specific regulatory preferences and standards, ensuring consistency across global teams and reducing the burden of training new reviewers on complex internal guidelines. This also removes the need to manually check each piece of promotional material against constantly changing guidance. 

As companies increasingly adopt modular content strategies, Revisto enables the creation and maintenance of modular content blocks while maintaining complete traceability and linkage to all final assembled materials. The platform tracks how each module is used across different promotional pieces, automatically validating proposed assemblies against regulatory requirements and ensuring that any updates to modular content are systematically reflected in all related final materials. This removes the manual overhead of maintaining complex usage matrices while ensuring that modular approaches don't compromise compliance.

Reach out today to schedule a demo and see the power of Revisto for yourself. Then, stay tuned for the next profile in our Role Call series.