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By Thomas Lodeweyckx, Associate Medical Director, SGS
By Thomas Lodeweyckx, Associate Medical Director, SGS
For many early-stage biotech and pharma teams, regulatory feedback feels like a threat. You have built your study design, modelled your dosing regimen and you are finally ready to move. But then questions start rolling in from the agency with doubts, stipulating conditions which might cause delays. You feel like you are back to square one.
But here is the reality: regulatory pushback is not failure. It is friction that sharpens your thinking. In fact, if your design never triggers a single hard question, chances are you are not doing anything very innovative.
“Pushback means they are paying attention. And if you have done the work, that is exactly what you want.”
It is easy to see regulators as gatekeepers. Bottomline: the health authorities want the same thing you do. A study that is safe, smart and built to generate high-quality data.
The challenge is that biotech and pharma teams often treat feedback as a block, when really it is just a signal to clarify your rationale, revisit your data and fill the gap in your story. And yes, it takes effort. But if you put in that work before submission, you do not just get approvals – you get confidence in your design.
“Regulatory hurdles are not necessarily roadblocks – they are checkpoints that keep your trials on the right path.”
Not every design will be textbook or fit neatly into a guidance document that outlines their expectations, recommendations and accepted practices for conducting clinical trials or submitting data. Especially if you are working with:
We have helped sponsors defend all of the above. And we have seen what works.
The key? Do not limit yourself to the limitations of the regulatory playbook. Show that you understand the spirit of it and how your plan aligns with that. And if you believe in your rationale, stand by it professionally, calmly and with the data to back it up. Because smart regulators respect well-prepared confidence.
This is often overlooked: your regulatory positioning is not just about paperwork, it is part of your trial design. And if you wait until submission to think it through, you are too late.
At SGS, we build regulatory logic into the protocol from the start:
This is where internal alignment and early strategic input make all the difference.
The best early-phase teams don’t try to avoid feedback. They plan for it, learn from it and use it to strengthen their study.
If you are about to submit and worried about what regulators might say, ask yourself: “Have I made it easy for them to understand what we are doing and why it matters?” If not, you are not ready. But the good news? With the right support, you can be.
Talk to one of our early-phase consultants like Thomas Lodeweyckx – or start with our 20-question self-assessment tool.
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
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