Anteris by Kymanox focusses on supporting biological products, injection devices, medical devices, IVD, combination product developments, compliance projects and ISO 13485 compliant QMS set-up for pharmaceutical, biotech and medtech clients. Anteris by Kymanox provides integrated, end-to-end solutions throughout the product lifecycle – from development through commercialization and post-market support.

ISO 13485:2016 certified Expertise and capabilities in biologics, biosimilars, medical device, & IVD including: – Product & Process Development – Regulatory Consulting with Health Authorities, Dossier Compilation, & Review – Human Factors Engineering – Risk Management, Technical File Compilation, DHF, & DV – Project Management