KORAVIE LIMITED, a UK-based start-up, partnered with Obelis Group to navigate the complexities of UK medical device registration. With expert guidance and hands-on support, they transformed regulatory uncertainty into a successful market launch—laying the groundwork for EU expansion.
From 1 July 2025, the EU will enforce new limits on Homosalate in cosmetics, allowing a max of 7.34% in face products. Reformulation may be required to ensure compliance.
A number of regulatory requirements must be taken into account when introducing medical devices into…
Understand who qualifies as the data controller in clinical investigations under the EU MDR and GDPR. Learn the roles of sponsors and investigators, the implications of joint controllership, and the legal responsibilities tied to personal data processing in clinical trials.
The global medical device industry operates within an increasingly intricate regulatory web. As healthcare innovation…
The European Union represents one of the world’s most valuable and influential cosmetics markets, valued…
HELLO CHAKRA LLC, a U.S.-based wellness brand, set out to expand into the EU and UK with a new product line under the General Product Safety Regulation (GPSR). With expert guidance from Obelis Group they successfully navigated product classification, documentation, and compliance—ensuring a confident and well-prepared market entry.
In June 2022, Quebec passed Bill 96, An Act respecting French, the official and common language of Québec, which amended the Charter of the French Language. These amendments significantly affect labelling and advertising requirements for businesses, including those in the cosmetics industry.
TrailHeads, a U.S. outdoor brand, partnered with Obelis Group to navigate GPSR compliance and launch successfully in the EU, overcoming Amazon-related challenges and accelerating their market entry.
Medical Devices (Pvt) Ltd. partnered with Obelis Group to overcome regulatory challenges and successfully launch in the EU, UK, and Swiss markets with expert support and streamlined compliance.