From signal to action: making regulatory intelligence work across the enterprise 

Why does regulatory intelligence matter more than ever? 

UCB’s strategic lead in patient supply opened with the business case. Patient supply at UCB covers the full value chain, from CMC development and clinical through to commercial manufacturing and supply, so the signals her team needs to watch go well beyond core GxP compliance into sustainability, technology, geopolitics and policy, all against the backdrop of a fast-moving pipeline and ongoing acquisitions. 

In that kind of environment, the job shifts from knowing what has changed to understanding what may change, what matters and what to do about it. She set out two conditions for regulatory intelligence to work as a real strategic lever: 

1. Being anticipative, which means going beyond the must-do and learning to tell an enduring trend apart from volatile noise. 
2. Calibrating the response by benchmarking how others are reacting, because acting too late carries a cost, but so does overreacting or moving too early, which can leave a company at a competitive disadvantage. 

The aim is to make early decisions for long-term value. 

Why is connection, not information, the real problem? 

UCB never had a shortage of intelligence. As the moderator explained, intelligence existed everywhere in the organization: signals arrived from many sources and jurisdictions, and the expertise needed to interpret them sat across legal, regulatory, quality, operations, the business and external partners, each working at a different level of maturity. The challenge was that all of this intelligence wasn’t adding up to insight the enterprise could use. 

The panel described where that tends to break down: 

• Ownership and prioritization. UCB’s legal representative pointed out that signals were already reaching the organization. What was missing was clear ownership, a way to prioritize and a way to coordinate the response, and without those, teams can easily end up working on the same signal in parallel. 

• Assessment that stops short of action. The Quality Assurance representative explained that an assessment only creates value when it leads to a decision and then to action, and that assessments which stay within a single function rarely get that far. 

The value of regulatory intelligence comes from end-to-end visibility, from the moment a signal is first identified through to its implementation. 

What does it take to build an enterprise regulatory intelligence capability? 

UCB described four building blocks, which don’t happen in sequence so much as develop alongside each other and reinforce one another over time: 

1. Understand the business need, including the current state, the pain points, the gaps and the opportunities. 
2. Align around a common foundation of sponsorship, shared language and a shared methodology. 
3. Connect the organization through an operating model with clear governance, roles, collaboration and decision pathways. 
4. Enable and scale the capability through technology and data, adoption and expansion, so that it lasts. 

People, culture and change management run through all four. 

Underneath the building blocks sits a common backbone that every function follows. Signals are spotted early and captured, logged and prioritized, then distributed to the right people, who assess the impact and agree a response, before the actions are tracked through to completion and the loop is closed. 

While the backbone is shared, the way each function works within it doesn’t have to be. UCB’s Regulatory Affairs representative said the aim isn’t to have everyone doing regulatory intelligence in the same way, but to make sure information reaches the right people and doesn’t fall between functions. Quality will ask whether a change affects compliance and should trigger implementation, while Regulatory Strategy will want to know what it means for assets, the portfolio and evidence that has already been generated. Alignment matters most in the backbone itself, in how signals are picked up, connected to the wider enterprise and acted on. The panel summed this up as consistency rather than uniformity. 

Who owns a signal? The PPWR example 

To make the model concrete, the panel worked through a single signal, the EU Packaging and Packaging Waste Regulation (PPWR). When the audience was asked who would own it if it landed tomorrow, the room split between legal, regulatory affairs and the business, which rather proved the point that no single function can see the whole picture. 

What comes out of this is one signal viewed from several perspectives, leading to one coordinated response, with an accountable owner who leads the work but doesn’t make the decision alone. 

The Quality Assurance representative talked about three things that made that kind of collaboration work at UCB: 

1. One accountable owner for each signal, who keeps end-to-end visibility even when other people carry out the tasks. 
2. Clear decision rights, so that everyone knows who assesses, who decides and who implements. 
3. Connections to existing processes, including the QMS for controls, CAPAs and document updates, and regulatory processes for portfolio decisions, such as stopping a clinical trial in a particular country after a new requirement comes in. 

There is a need for a clear escalation path for when things stall, without adding extra layers of governance. In the case of PPWR, UCB is tracking actions in its regulatory intelligence platform from the first signal through to an implementation that will run over several years. 

How is regulatory intelligence becoming a board-level input? 

Perhaps the clearest shift to come out of the RAPS RICE event was a clear change in who regulatory intelligence now serves. It is still about protecting the license to operate, but it is increasingly feeding the decisions that leadership teams and boards make about where to compete, what to invest in and which risks they are prepared to carry. 

UCB’s strategy, risk and compliance lead described three things that leadership brings to this: 

• Direction, by placing regulatory intelligence in the corporate strategy framework from the outset, so that emerging trends are mapped against the strategic choices the company will have to make. 

• Sponsorship, which in her experience is won by translating business impact into risk exposure. Doing that links regulatory intelligence to enterprise risk governance, and at UCB, PPWR was framed as an enterprise risk with leadership sponsorship to give it the visibility and traction it needed. 

• Priority, with criteria that score exposure as well as compliance, including the effect on growth and on the future pipeline, so that the business understands why it should act now and not only why it should act at all. 

Escalation is deliberately selective. Only the few items that really matter go up to the C-level, which doesn’t want to see every detail, while everything else stays with experts who are empowered to make decisions and move at the right pace. 

When asked what the business wants from regulatory intelligence, the business strategy lead’s answer was “as simple as possible”. In practice, that means a regular and selective report, such as a monthly view of the health of key signals and the response strategy, backed up by direct alerts when something urgent lands. It also means connecting to the governing bodies that already exist rather than creating another place where decisions have to be made, which at UCB means the bodies responsible for strategic direction, for the operational response and for allocating people, OpEx and CapEx. The aim is to give the business confidence that it won’t miss important information, or an important decision. 

The same theme came up in other sessions at RICE. Intelligence earns its value when it changes a decision, and for leadership teams that means the question moves from whether the company is compliant to which products it should keep and where it should invest, with answers framed in time, money and risk rather than in articles and annexes. 

The poll results suggest most organizations still have some way to go, with only 12% of the room saying their intelligence already informs broader business decisions. UCB’s own ambition is explicit about the destination, which isn’t better monitoring. It is a gradual move from reacting to change and meeting requirements, through informing strategy and investment decisions and anticipating what is coming, to influencing and helping to shape what comes next. 

Where does technology help, and where do people decide? 

Roger Kruger, Executive Vice President, Commercial at Infodesk, described what technology does well. It helps teams pick out the right signals from the noise and make quicker, better-informed assessments, and it can record where each decision was made and who made it, in a workflow that every function can see. Where it stops, in his view, is at each organization’s own operating model and the behaviors that come with it. 

“Good technology should be enabling the right signals to go to the right people, to do the right assessments, to make the right decisions, and take the right actions.”  Roger Kruger, Infodesk 

He added that when teams can see the documentation and steps that others have already taken, they avoid duplicating work and can repeat what has worked before instead of starting from scratch. In UCB’s case, the technology was shaped around their operating model rather than the other way around, with room to pilot and adjust as the model evolved. 

The QA/ QI lead UCB was equally clear that a platform on its own isn’t the answer. It brings visibility to the flow of signals, assessments and actions, but it only works when there is a strong process behind it, responsibilities are clearly assigned and people are willing to own the decision and the action at the end. 

Not every signal needs an action, but every signal does need a decision, and while technology can help teams see more, it is people who make that call. 

What was harder than expected? 

The panel was candid about the parts of the journey that proved more difficult than anticipated: 

• The signals themselves have become more complex. Geopolitics is blurring the line between regulation and policy, so teams now find themselves tracking draft bills and even communication strategies, and having to judge whether a trend will last or is tied to a single administration. 
• Anticipation needs protected time, because short-term must-dos have a habit of crowding out the forward-looking work. 
• Transformation takes longer than planned. Experts need support from their managers to give time to cross-functional work, and adoption is a long journey rather than a box to tick. 
• Maturity varies from one domain to another. UCB applies the same process to all regulatory information, GxP and non-GxP alike, but the people assessing a new AI, packaging or manufacturing regulation don’t all bring the same skills, so UCB piloted the approach first and has been scaling it domain by domain. 
• Tools only connect when the process does. The Quality leader’s advice was to connect regulatory intelligence with the QMS early and to define the process first, because tools can only be joined up once the process behind them is clear. Not every signal ends up in the QMS, only those with a compliance impact. 

Five lessons for making regulatory intelligence work across the enterprise 

The panel closed with five lessons that apply well beyond UCB: 

1. Enterprise sponsorship, because an enterprise ambition needs leadership, ownership and governance behind it. 
2. Business need first, starting from the decisions the business needs to make rather than from the tool. 
3. One backbone, meaning a shared way of working that still leaves room for each function’s expertise. 
4. A visible journey, from intelligence to impact, action and decisions. 
5. Treating it as a transformation, since this is about changing how people work, not implementing a system or writing a new SOP. 

How Infodesk helps 

Most of the challenges the panel described begin once a signal has been found, and that is also where much of Infodesk’s work with regulatory and quality teams sits. Infodesk monitors and curates health authority and policy updates, and the Workflow Solution then routes each signal to an accountable owner and the right experts, records the assessment and the decision, and tracks the resulting actions through to completion in a single view that every function can see. It is configured around your operating model, taxonomy and governance, rather than asking you to change them to fit the tool. 

FAQ 

What is enterprise regulatory intelligence? It is regulatory intelligence run as a shared capability across the organization rather than separately within each function. Signals follow one common process from detection through to action, while each function brings its own expertise to the assessment. 

Why isn’t finding regulatory signals the main challenge any more? For most teams, the bottleneck has moved from finding signals to acting on them. At RAPS RICE 2026, only 13% of attendees named finding signals as their biggest challenge, while 44% named assessing business impact. 

Who should own a regulatory signal? A single accountable owner, supported by every function the signal affects. At UCB, that owner keeps end-to-end visibility, while the rights to assess, decide and implement are clearly set out. 

How does regulatory intelligence support board-level decisions? By framing a small number of important signals in terms of risk exposure, time and money, and routing them into the governing bodies that already make decisions on strategy and resources