Axendia: A Trusted Adviser to the Life-Science and Healthcare Industry

Daniel R. Matlis began his career as an electrical engineer at Johnson & Johnson. With the advent of Computer System Validation and 21 CFR Part 11 remediation efforts, he joined a leading Life-Sciences consultancy. When he moved ahead from his role as VP and GM, he set out to explore the missing link between industry, regulators and solution providers. As he entered into extensive discussions with leaders of life-science firms and regulatory agencies, he discovered an unmet need for a firm that provides a holistic view of the industry by offering trusted advice on business, technology and regulatory issues affecting the life science ecosystem. Driven to successfully address this need, Matlis went on to launch Axendia, a leading analyst and strategic advisory firm. Since 2005, Axendia has maintained trusted relationships with regulators, industry executives and technology and service providers.

Axendia is not just another conventional consultancy; as a trusted advisor, the firm provides strategic insights and analysis on abroad range of industry trends and challenges.

A key differentiator is Axendia’s long term relationship with regulatory agencies. Based on the trust it has established with the Agency, the firm has provided input to FDA on quality and regulatory strategies, and has presented findings from its primary research to Agency leadership and staff. Axendia is also actively involved in the Medical Device Industry Consortium’s (MDIC) Case for Quality initiative and has been since its inception. Axendia’s relationship with regulators has resulted in a deep understanding of the shifting regulatory landscape.

A significant factor for the success of these extensive services is Axendia’s unique approach of providing tailored services. “We believe that there is no one standard solution that fits all clients, therefore our approach is to offer tailored solutions that take in to consideration each client’s present, as well as their future needs,” states Matlis, President and Founder, Axendia.

Axendia’s team takes a holistic approach when working on enterprise technology projects. A recent engagement substantiated Axendia’s unique and knowledge-driven expertise. When the client, a leading life science firm, approached Axendia with a specific requirement of replacing their quality management system, Axendia first executed a 360 degree assessment of the organization.