Hisut Biomedical

Hisut Biomedical Ltd is a specialized life sciences consultancy providing strategic regulatory affairs, clinical development, and quality assurance services. The firm operates as a boutique consultancy, often collaborating with larger groups like Atheln Biomed to support pharmaceutical, biotech, and medical device companies in navigating complex global regulatory pathways. The company focuses on high-level strategic advisory for product development, from concept to regulatory approval. It leverages the deep expertise of its founder in handling over 100 regulatory submissions and agency meetings with the EMA and FDA, covering a wide range of modalities including small molecules, biologics, and implantable medical devices.