How Medical, Legal and Regulatory (MLR) reviews can be cut from weeks to days

Pharmaceutical MLR processes are under more pressure than ever: increasing content volumes, compliance processes under strict direction, and the increasing demand to do more with less. When applied in the context of the Life Sciences, backed by trusted, structured data, AI can reshape how leading organisations approach MLR - not by replacing expert judgement, but by enhancing it with further clarity.

This enlightening session hosted by Datapharm, titled “How to Cut the Medical, Legal and Regulatory Review Process from Weeks to Days”, brought together Code experts and pharma technology leaders to address one of the most persistent operational bottlenecks in UK pharma: the slow, resource intensive approval of promotional materials.

Speakers: Dr. Sarah Clarke (Founding Advisory Board Member, Siguru AI ), Dr Rina Newton (Founding Advisory Board Member, Siguru AI ), Daniel Bentley (Co-Founder & Chief Product Officer at Siguru AI ), Harry Bliss (Co-Founder and CEO at Siguru AI) 

Moderated by: Adam Smith, (Global Partnerships Director, Datapharm)

Why MLR needs a rethink

Pharma’s marketing output has grown dramatically - particularly digital assets. Yet review processes remain rooted in systems “built in the noughties.” As Harry Bliss noted, innovation has not kept pace with the volume and complexity of materials, leading to lengthy approval cycles, repeated review rounds, and delays to market. Compared with other regulated industries such as finance and legal, pharma’s review infrastructure, and the speed at which it operates, has fallen behind.

In short, time is the industry’s most precious commodity and the current MLR process consumes too much of it.

AI is a confidence booster, not a replacement

A central theme was the appropriate role of AI in MLR. The speakers emphasised that AI should augment human reviewers, not replace them. As Code Expert, Sarah Clarke, put it, “AI does not absolve us of any responsibility at all.” Signatories remain fully accountable for decisions, and the PMCPA will continue to expect clear justification for every claim and reference.

But AI has enormous potential to add value with:

• Speed – surfacing issues in seconds rather than hours
• Consistency – applying the same checks every time
• Reduction of review fatigue – highlighting what needs human judgement
• Improved first‑time quality – enabling marketing teams to submit cleaner drafts for review

How an industry-backed MLR tool works – and how it aligns with the ABPI Code

Siguru AI’s tool, demonstrated live during the session, operates as a browser extension, allowing it to analyse multiple types of assets, be it webpages, PDFs, emails, or speaker decks. This is particularly important for dynamic content, where dropdowns, pop‑ups and mobile layouts can introduce compliance risks.

Key capabilities include:

1. Automatic detection of ABPI‑required elements

The tool identifies missing or incorrect mandatory components which could include inverted black triangles, prescribing information, adverse event reporting statements and layout‑dependent omissions (e.g. missing elements in mobile view).

Because it integrates with product information on emc (electronic medicines compendium), the tool can pull the current SmPC automatically, ensuring alignment with the latest approved information.

2. Claim identification and substantiation

The tool extracts promotional claims, breaks them into sub‑claims, and checks each against the referenced evidence. It can automatically fetch open‑access references and highlight mismatches - for example, when a numerical value in a graph does not match the cited study.

This granular approach mirrors the ABPI Code’s requirement that every word of every claim must be supportable, a point reinforced by Sarah: “The devil really is in the detail.”

3. Customisation to company SOPs

Siguru AI can also be tailored to individual company processes, ensuring alignment with your internal governance.

Why structured medicine product information matters

Structured data is essential for safe, scalable automation in a regulated environment, and by pulling the SmPC directly from emc, the tool ensures reviewers and marketers are working from a single, authoritative source. This structured product information data also enables faster, more accurate checks, automated detection of missing qualifiers or population restrictions, and reduced risk of outdated or inconsistent information.

Why Code experts chose Siguru AI

Two of the UK’s most respected ABPI Code experts, Sarah Clarke and Rina Newton, explained why they chose to support Siguru AI as an MLR AI partner.

Rina highlighted that they had reviewed many tools, but Siguru AI stood out for a few reasons: firstly, because it directly addresses pharma’s real pain points. It is also built to benefit many and not just the few at the very top, and as a partner solution, not just an off‑the‑shelf product. Lastly, it has demonstrably been able to reduce review cycles from weeks to days.

Sarah added that Siguru AI was the first tool that genuinely excited her, because it “can really help us” by reducing manual work such as reference linking and breaking down claims into sub-claims - tasks that currently consume hours of reviewers’ time.

Learn more about keeping your content up to date with the latest medicines information

Datapharm supports leading companies in the Life Sciences and Healthcare with an API service, ensuring the latest SmPC information is automatically pulled from the electronic medicines compendium (emc). To learn more about how we can help, contact our team.

Take AI-enabled efficiency to MLR in your business

Our panellists made a compelling case that AI‑enabled MLR is not about replacing human expertise, but empowering it. For Pharma medical, legal, regulatory and marketing teams, the message was clear: the future of MLR is faster, safer and more collaborative, and it’s already here.

To learn how Siguru AI could help your business, or to request a test run of the solution on your own materials, please arrange a call with Siguru AI Co-founder Harry Bliss: