Client Success Story: Koru Pharma Co., Ltd.
Koru Pharma Co., Ltd., a South Korea–based manufacturer, partnered with Obelis Group to support the UK regulatory pathway for one of their advanced medical products. While already experienced in regulatory matters and equipped with strong documentation, their team wanted clear and practical guidance to navigate the specific requirements of the UK regulatory framework.
With the support of Obelis consultant Mikulas, the process progressed in a structured and efficient way, allowing the company to confidently move forward with its UK market plans.
Q: What regulatory support did you need from Obelis Group?
“We required support for the UK registration of our product. Although we were familiar with regulatory requirements, we had several detailed questions about the MHRA portal procedures, the applicable fees, and the differences between the EU Authorized Representative and the UK Responsible Person. We also wanted clarification regarding distributor responsibilities in the UK.”
Q: How did Obelis Group support you during the process?
“Mikulas provided clear and structured explanations to all of our questions. He guided us step by step through the MHRA portal process and helped us fully understand the UK-specific requirements. His practical approach made the regulatory procedures easy to follow and manage.”
Q: What was the outcome of the collaboration?
“The UK registration was completed successfully, and our products are now on the UK market. The process was handled smoothly, and we appreciated the clear communication and well-organized support throughout the project.”
Q: What stood out most about working with Obelis Group?
“The clarity, responsiveness, and depth of expertise stood out. Even with our internal regulatory knowledge, the additional insight and structured guidance provided by Mikulas and the Obelis team added real value.”
Today, Obelis Group acts as our UK Responsible Person, supporting our continued compliance and presence on the UK market. We value the collaboration and look forward to working together in the future.
At Obelis Group, we don’t just help you comply – we help you succeed.
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