Many well-known life science companies already rely on the performance of our products and services, so we decided to let them have their say. To this end, we have launched a new series of interviews in which we hear from them directly how they support our customers and what makes working with them so special.
Join us for the second part of this series, where we meet EURSvalidator. In a short interview, this hidden champion tells us about topics such as work ethic, supporting the submission process, and the importance of a close relationship with the regulatory agencies.
Hello EURSvalidator! Thank you for joining us today. Can you start by introducing yourself?
Hello everybody, I am EURSvalidator, the bridge that connects the pharmaceutical industry and the regulatory agencies. I am the official electronic submission validator for over 35 global regulatory agencies, entrusted with checking the validity of incoming submissions from the pharmaceutical industry. I am trustworthy and reliable, and I always deliver. I am working 24 hours a day, seven days a week, but I can do that because I am the strongest bridge that was ever built.
You are an experienced member of the EXTEDOpulse team. One could say, our compliance specialist. How did that happen?
Thank you; I am quite humbled by that. For me, the key is the close connection that we have built with the agencies and the pharmaceutical companies, so it is not just me; it is really a team of products working on this. We are nurturing relationships that enable us to build trust and help us to shape the agency requirements proactively to deliver global standards. Each agency has slightly different needs, so we work closely with them, listen, and tailor solutions. One size rarely fits all.
Could you elaborate on your role and how customers benefit from it?
They benefit because it saves them precious time. If I support them with their validation, they can trust that the agencies are doing the same. So, if the application passes its validation, it will be able to be submitted to the agencies. I act as the quality gate between the preparation, submission, and acceptance parts.
This sounds very interesting but also demanding. Where do you source all the information?
For new agencies working with EXTEDO, we collaborate to develop a regulatory standard, which I integrate. Then, the industry and agency will use it to make sure the submission can be accepted. Just recently, I was able to support another important agency in introducing eCTD. If it’s existing agencies, our longstanding relationship with them helps because they normally will talk to us before implementing a change, and we do that together.
Working in the Submission team, positioned at the process's end to check results, seems quite responsible. How do you manage that?
My work is essential but often unseen. Thanks to EXTEDOpulse's platform approach, I work in parallel with the submission process. This allows everyone to fulfill their tasks, and in the background, I ensure the submission is valid for the agency. I'm at the end of the industry process, taking over the last step - the validation - which is basically done by the agency again once the submission arrives there. I act like a bridge facilitating the handover.
If people would like to work with you, where can they find you?
Well, I have my own website - EXTEDO EURSvalidator - EXTEDO's NeeS and eCTD Validator | EXTEDO – where you can contact me. Of course, you can always ask your Account Manager if you already have one. I am looking forward to working with our readers and hope you all have a nice day!
We appreciate your time in sharing these insights - a truly informative and engaging conversation. Thank you!
Would you like to meet another one of EXTEDO’s offers?
Read the Interview with our Regulatory Publishing Services offer!
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