Client Success Story: Kogenebiotech Co., Ltd.
Kogenebiotech Co., Ltd., a South Korea–based company, partnered with Obelis Group to support their EU regulatory activities for an IVD Class A notification. As a valued VIP client, Kogenebiotech was looking for precise regulatory support and clear communication to ensure a smooth and compliant notification process.
Our consultant, Katie, worked closely with their team to align expectations, clarify procedures, and ensure full understanding of both regulatory requirements and Obelis’ internal processes.
Q: What regulatory support did you need from Obelis Group?
Sungil, General Manager Global RA, Kogenebiotech Co.,
“We required support for an EU Class A IVD notification. While we were already familiar with regulatory requirements, it was important for us to clearly understand the specific expectations and procedures, particularly in relation to the Belgian authorities.“
Q: How did Obelis Group support you during the process?
“Katie provided exceptional support with deep regulatory insight. She didn’t just answer our questions; she proactively guided us through the complexities of the Belgian authorities’ requirements. Also, Her clear explanation of Obelis’ internal processes and document flows gave us confidence at every step.“
Q: What was the outcome of the collaboration?
“The notification process was completed smoothly and efficiently. Thanks to the clear guidance and detailed communication, we were confident that all requirements were met and that the submission was properly aligned with EU expectations.“
Q: What stood out most about working with Obelis Group?
“Beyond professionalism and transparency, what stood out most was Katie’s genuine dedication and helping mindset. She treated our project with the utmost priority, showing remarkable patience and expertise. Working with her felt like having a true partner who genuinely cared about our success.“
With Obelis Group’s support, Kogenebiotech Co., Ltd. successfully completed its EU Class A IVD notification. We are pleased to support their regulatory activities and value the strong collaboration built through this project.
At Obelis Group, we don’t just help you comply – we help you succeed.
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