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.

It was determined that the biggest issue was not simply the technology but the underpinnings of the manufacturing compliance and quality management processes.

Axendia utilized its unique methodology, which includes a gap analysis and detailed current-to-future state roadmap. Going beyond a technology strategy, this approach addressed organizational culture, people, processes, regulatory frameworks, and business strategies. As a result, the client has an effective strategy to not only meet its business, technology and regulatory requirements but also one that helps them structure an efficient enterprise architecture and governance processes. The end result is a sustainable and scalable quality management system that meets their business and regulatory needs.

We believe that there is no one standard solution that fits all clients, therefore our approach is to offer a tailored approach that takes in to consideration each client’s present, as well as the future needs

Axendia also advises technology and service providers, ranging from organizations in Fortune’s Technology top 20 companies to start-ups. Axendia analysts provide market research analysis and strategy, to ensure technology and services meet the needs of the Life-Sciences and Healthcare ecosystem. However, Axendia remains an independent analyst firm providing vendor-neutral advice, recommending only solutions that best fit with each client’s unique requirements and goals. To maintain its independence, Axendia does not sell or implement technology solutions.

Axendia’s imposing reputation in the Life-Sciences and Healthcare space can be attributed to its dynamic work culture built on the values of respect, integrity and passion. “Axendia is composed of industry analysts with decades of experience. As a result, we offer a unique combination of hands-on experience coupled with strategic vision,” remarks Matlis. Axendia is committed to building and nurturing long term relationships with its clients, fostering a spirit of cooperation, collaboration and trust with every single engagement.