From Life­cycle Con­trol to Sys­tem Trust

Matthias Pohl is Managing Partner at InterPharmaLink, a boutique consulting firm specializing in due diligence support, pharmaceutical quality, regulatory compliance and operational excellence across the life sciences value chain. He brings over 30 years experience in the industry thereof 27 years at Novartis – across development, operations, quality, and EHS on both the generic and pharma side – as well as a subsequent role heading Global Quality Operations at CSL Behring.

Matthias joined the Coopers Life Sciences Circle in April 2026 and contributed his know-how with our audience. We took the opportunity to gather his insights in the following interview.

Coopers: You positioned your session as moving "from lifecycle control to system trust." What does that shift mean?
Matthias Pohl (MP): Inspectors are changing. In the future, it is no longer about having the right documents, it is about whether your system actually works. That is what I mean by trust in your system. In due diligence, you quickly see that procedures can look perfect on paper but don’t reflect reality. What really matters is your data: how it is generated, maintained, and kept under control over time. It is about resilience, proving that your system is continuously in control, not just at a single point in time when documents are reviewed.

Coopers: You introduced the audience to ELSA, something readers may not have heard of. What is it and why does it matter?
MP: ELSA is the Enterprise Learning and System Analytics platform the FDA is using, a major step towards data driven regulation. They feed large volumes of regulatory and operational data into it and use it across multiple areas: submission screening, audit preparation, data review, and pharmacovigilance. The impact is significant: regulators are becoming much more efficient. They request more data upfront and can analyze it faster, often identifying trends or deviations before companies do themselves. If you don’t have comparable data capabilities internally, you are at a real disadvantage.

Coopers: What are the key regulatory inflection points you are watching right now?
MP: There are four key inflection points across both the US and EU:

• Digital and AI regulation: The FDA has released a draft AI framework, and in the EU, Annex 11 is being updated to reflect today’s digital reality. In addition, Annex 22 will specifically address the use of AI in pharma.
• New inspection approaches: There is important new guidance on risk-based remote regulatory assessments, which is changing how inspections are conducted.
• Supply chain accountability: The EU is increasingly holding manufacturing authorization holders responsible for continuity of supply across their supply chains; something the US has emphasized for longer.
• Maturity over existence: The FDA is moving beyond checking whether a quality system exists, toward assessing how mature and effective it actually is.

Coopers: You also talked about how inspections themselves are changing in format.
MP: Inspections are becoming more hybrid and data-driven. Typically, they now start with extensive data requests, far beyond what we saw in the past. This is often followed by a remote assessment, a trend that accelerated during COVID, and then a risk-based on-site inspection if needed.
At the same time, regulators are becoming more assertive. The FDA has already started conducting unannounced visits in Europe. In several cases, a companies allowed entry even though there was normally a requirement for advance notice.

The signal is clear: if you want to operate in global markets like the US, you need to be prepared for inspections on the regulator’s terms.

Coopers: What does all of this mean in practice for companies?
MP: The key message is: your system must be working, and it needs to be able to prove that it works even under worse conditions. Not only when the sun is shining, but even when you have deviations. For that:
1) You need, as I call it, an inspection-ready data layer. You need to move your data out of fragmented or paper-based environments into an accessible, inspection-ready data layer, and build something so that you have access to the data you actually hold. Many in the industry don't do this yet. But I believe nobody will get away with it forever – and the business case makes itself.
2) You need to have AI models embedded in your systems as GXP-relevant systems. That is still a learning curve for both sides, regulators and industry, but it is coming. And the core of it is change control – moving away from a paper exercise of change initiated, change closed, and forgotten. The expectation now is not just to document a change, but to actively monitor its impact and verify that it delivers the intended outcome.

Coopers: You mentioned biosimilars as a concrete example of where data is becoming decisive.
MP: Biosimilars are a significant and very visible change happening right now. Historically, approval required analytical comparability, PK/PD data, and typically a clinical trial to prove efficacy and safety. Now, if you have the right data, it is possible to waive that clinical trial step. Think what that means: development time shrinks, cost shrinks, the entry barrier into the biosimilar market drops considerably. We have many clients working on this. Some are successful, but some are not. The risk is that companies hear the positive message – clinical trials can be waived – but underestimate the prerequisite. In reality, the bar for analytical data becomes much higher, not lower. This only works if you have the right data and control. Otherwise you cannot manage the amount of data involved. And just in one due diligence we recently did, the company is planning to file more than 10 new biosimilars in the next one to one-and-a-half years. The approach is working, but only when the data is there.

Coopers: And for advanced therapies?
MP: Regulators are allowing more flexibility at the beginning of the process for advanced therapies. It is still not fully clear how it develops, but they have become more flexible than in the past to a certain extent. That said, the requirements ultimately remain the same, and they become more strict post-approval.

Coopers: What is your core advice for organizations preparing for this environment?
MP: I would say:
1) Rehearse for hybrid inspections. Do not wait to be tested by regulators.
2) Test your data as it actually exists, not as it is described in SOPs. In the future, the most important asset is not your documentation, but the trustworthiness of your system.
3) Quality exists for patients and should never be done for regulators.

I have seen this very directly during my time at a large pharmaceutical company, when we were facing global drug shortage for oncology injectables, as all manufacturers of these products struggled with quality issues. We received letters from parents whose children had no access to medication due to the shortages. That puts everything into perspective.
Therefore, right-first-time is not only the most efficient and cost-effective approach, it is ultimately about patient safety.

Thank you for your time and your insights, dear Matthias.

Conversations like this one are what the Coopers Life Sciences Circle is built for. The CLSC offers Life Sciences professionals an opportunity for exchange in a relaxed atmosphere; the evening in April was rated 4.9 out of 5 by participants.

If you would like to join, the next CLSC takes place on October 22, 2026. 
Your can register here, attendance is free of charge.

We look forward to seeing you there.
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