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Company profile	anteris medical, together with sister company anteris helvetia and strategic partner Kymanox, is a globally renowned professional services provider, supporting their clients from the biopharmaceutical, biotech, and medtech industries in the selection of technologies, product development, and registration in regulated markets. anteris project support ranges from support and remediation of development projects, compilation of technical documentation, support in the setup of quality management systems and manufacturing, regulatory strategy and implementation, all the way to support of clients who wish to introduce their biopharmaceutical product in additional regulated markets. An area of particularly deep expertise is the market for bioimilars, where anteris helped to develop and introduce more than a dozen products to various markets.
Products & Services	Development Services: • Support with drug substance and drug product development • Definition of target product profile • Specific support of biosimilar product development • Establishment of technical documentation (DHF) for audits and registration • Establishment of quality management systems (ISO 13485, 21 CFR 820) • Conduct of human factors studies • Product specifications, design verification and validation Regulatory and Quality Services: • Development of regulatory strategy for most regulated markets • Gap analysis and remediation depending on target market • Preparation of regulatory documentation, dossiers, and interaction with relevant Health Authorities • Notified body opinions (NBOps) Manufacturing Services: • Support and conduct of tech transfer • Support in planning, implementation, and commissioning of manufacturing facilities • Process validation • Audit preparation and mock audits Focus Areas and Expertise: • Biosimilars and complex generics • Novel combination prod
Target group	Anteris medical seeks additional customers worldwide who desire to introduce their products for global regulated markets, with a focus on the European and US markets. Products, anteris offers to support in their development and registration, include medical devices, in-vitro diagnostic products, and drug/device combination products (especially biosimilars).
Competitive advantages	anteris medical is uniquely positioned for the support of combination product market introduction, and draws experts from both, the life sciences and engineering. A recently concluded strategic partnership with Kymanox, NC, USA, makes the combined organization one of the largest consultancies worldwide in the field of combination products (300 experts), with arguably the broadest support offering.
Ideal Business Partners	Pharmaceutical developer/manufacturer, medical device developer/manufacturer, CDMO (contract development and manufacturing organization), biosimilar developer