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.
News
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.
Obelis Group Partners with IBA to Keep Beauty Brands Ahead of U.S. Cosmetic Regulations
Through our partnership with the Independent Beauty Association and our sponsorship of the Fiscal Note U.S. Policy Map, we equip beauty brands with real-time regulatory insights and expert support, helping them stay compliant with MoCRA and confidently navigate the U.S. market.
2026 Cosmetics Labelling Deadlines Impacting Global Compliance
The year 2026 brings numerous regulatory deadlines affecting cosmetic product labelling across several territories, including the European Union, United Kingdom, Switzerland, Canada, and the United States.
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.
Obelis Group Participates as Contributing Partner in the 10th ERPA Annual Summit 2026
Obelis Group will participate as a Contributing Partner in the 10th ERPA Annual Summit 2026, a key European forum uniting regulators and industry experts to discuss evolving expectations in EU cosmetics compliance and the practical responsibilities of the Responsible Person.
Finding the right balance: Sandra Ferretti on leadership and creativity
Sandra Ferretti is Chief Compliance Officer and Board Member at Obelis Group, working daily at the heart of regulatory complexity. Beyond compliance, she is also a singer. In this interview, she reflects on how structure and creativity come together in her life and influence the way she leads.
EU Proposal to simplify MDR and IVDR: what it is and why it matters
The EU has unveiled a proposal to simplify the MDR and IVDR framework, introducing updates designed to ease compliance and support innovation. Here’s what’s changing and what manufacturers need to do next.