Koru Pharma Co., Ltd. successfully entered the UK market with the expert regulatory support of Obelis Group. Through clear guidance on MHRA registration and UK-specific requirements, the process was smooth, efficient, and fully compliant.
Success Story
Seamless UK Compliance for Fragrance Portfolio Expansion
SUPERZ Perfume Kft. partnered with Obelis Group to ensure full UK compliance for 29 fragrance products. With expert guidance from Obelis consultant Sofia Rocha, all products were successfully reviewed and notified, enabling smooth market entry while strengthening internal processes for future growth.
Confident EU Market Entry Through Expert IVDR Support
Athenese-Dx partnered with Obelis Group to navigate the EU IVDR process, achieving full compliance and successful EUDAMED registration for their biochemistry analyser, enabling confident entry into the EU market.
Clear Guidance for a Smooth EU Class A IVD Notification
With clear guidance from Obelis Group, Kogenebiotech Co., Ltd. achieved a smooth, confident, and fully compliant EU Class A IVD notification through transparent communication and precise guidance.
Building Confidence for UK Market Entry
Luxe Assist Global Inc. partnered with Obelis Group to streamline compliance, refine labelling, and confidently achieve a smooth, delay-free UK market entry for their microneedle derma roller.
Accelerating Global Expansion Through Expert EU Regulatory Support
Obelis Group supported RF Medical Co., Ltd. with the efficient issuance of EU Free Sales Certificates, enabling compliant and timely medical device registrations in Jordan and Vietnam to support global market expansion.
Seamless MHRA Updates Enabling Continued Market Access for Dental Devices
Obelis Group supported RNDENT, a manufacturer of Class I dental medical devices, with a seamless MHRA registration update during account renewal, ensuring uninterrupted access to the UK market through efficient and compliant regulatory support.
EU Market Entry Success Story: RED Directive Compliance in 7 Days with Obelis VIP
Discover how Boundless Devices Inc., a U.S.-based technology company, successfully entered the EU market in just 7 days. With Obelis Group’s VIP service and EAR support, the company achieved fast and seamless compliance under the Radio Equipment Directive (RED), transforming regulatory complexity into a confident and efficient EU market launch.