Discover how Obelis Group supported REVE LTD. throughout its UK cosmetics compliance journey, from PIF review and CPSR preparation to SCPN notification, helping the company bring its lipstick to market smoothly, efficiently, and with confidence.
Testimonials
One Product, One Goal, Complete EU Compliance
Discover how Obelis Group supported Sanava AB throughout the complete EU cosmetics compliance process, including laboratory testing, CPSR preparation, PIF review and CPNP notification, helping the company confidently bring its night face cream to the European market.
Supporting a Smooth Path to MDR Compliance in Europe
Obelis Group supported Azista Industries Private Limited with an MDR review and EUDAMED verification, helping ensure continued compliance with EU regulatory requirements. Through expert guidance and practical recommendations, the project strengthened the company’s regulatory framework and supported its ongoing access to the European market.
Ensuring Ongoing UK Compliance Through a Smooth GPSR Update
KNBEAUTY Co., Ltd. partnered with Obelis Group to successfully update its UK GPSR documentation for a range of artificial eyelashes. Obelis ensured the company’s product documentation remained fully aligned with UK requirements, enabling uninterrupted market access with confidence.
Strengthening MDR Compliance Through EUDAMED Verification
With Obelis Group’s support, TTK Healthcare Limited successfully completed EUDAMED verification for its Class III heart valve devices, strengthening MDR compliance and supporting its continued growth in the European market.
Bringing Premium Skincare to the EU and UK Markets with Confidence
ODACITÉ partnered with Obelis Group to achieve EU and UK compliance for its Nourishing Lip Serum SPF 40. With support for safety assessment, product notifications, and regulatory guidance, the brand successfully brought its product to market with confidence.
Successfully Managing Large-Scale EUDAMED Compliance
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD. successfully completed large-scale EUDAMED verification for more than 1,100 medical devices with the support of Obelis Group, ensuring efficient EU compliance and smooth registration of Class Ir and Class Is devices.
Ensuring Seamless EU Market Continuity Through EUDAMED Expertise
Biobeat Technologies Ltd. successfully completed its EUDAMED verification and mandate update with the support of Obelis Group, ensuring uninterrupted access to the EU market through clear regulatory guidance and expert support.
Ensuring EU Compliance for High-Quality Cycling Components
Ritchey Design Inc. partnered with Obelis Group to ensure full EU compliance for its product portfolio under the GPSR. Through expert technical reviews and ongoing Authorized Representation, Ritchey reinforces its commitment to safety and excellence in the European cycling market.
Confident UK Market Access Through Expert Regulatory Support
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.