Obelix Regulatory

Obelis Group / Obelisk Regulatory

Global Regulatory Compliance, Authorized Representation, and Market Access Services

Obelis Group (operating via obelis.net / obelisregulatory.com) is a premier global regulatory consultancy founded in 1988. With over 35 years of experience and dual ISO 9001:2015 and ISO 13485:2016 certifications, the firm serves as an Authorized Representative (EC REP / UKRP) and regulatory advisor for over 7,000 life science, medical device, cosmetic, and consumer product manufacturers across 90+ countries.

Core Services & Regulatory Capabilities

• European Union & UK Representation: Acting as an official EU Authorized Representative (EC REP), UK Responsible Person (UKRP), and Swiss Authorized Representative (CH REP) to provide non-EU/UK manufacturers with legal market access.
• Medical Device & IVD Compliance: Navigating complex compliance pathways under the EU Medical Device Regulation (MDR 2017/745), In Vitro Diagnostic Regulation (IVDR 2017/746), EUDAMED registration, and technical documentation drafting.
• Cosmetics & Consumer Product Safety: Providing Responsible Person (RP) services, Cosmetic Product Safety Reports (CPSR), and regulatory compliance for non-harmonized consumer goods under the EU General Product Safety Regulation (GPSR 2023/988).
• Quality Management Systems & Audits: Assisting organizations in building and auditing ISO 13485 and ISO 9001 Quality Management Systems (QMS) to ensure continuous audit readiness.