IEM GMBH

Sobel Consultancy is a Brazil-based regulatory consulting firm specializing in medical devices, in vitro diagnostics (IVDs), and cosmetics. Recognized as the Top Medical Device Regulatory Consultant in Brazil for 2025, the firm provides strategic regulatory consulting, compliance support, and submission guidance across multiple markets including Brazil, USA, Europe, and Canada. Core services include regulatory strategy and market access, quality management systems (QMS) consulting, biological and toxicological evaluations, clinical evaluations, representation services with regulatory authorities, labeling and claims compliance review, and structured regulatory training programs. The company holds ISO 9001 certification and leverages Brazil's regulatory framework and skilled workforce to deliver cost-effective solutions for product development and market entry. Sobel Consultancy supports clients throughout the product lifecycle, from initial regulatory strategy definition to submission follow-up and ongoing compliance management.