Kymanox Creates Human Factors Edge with Acquisition of Agilis Consulting Group

Kymanox Corporation, a specialized professional services provider dedicated to the life science industry, has just acquired Agilis Consulting Group. Through their expertise in human factors, Agilis assists medical device companies in submitting successful and compliant regulatory documents, allowing them to bring safe and effective medical products to the global market. With this acquisition, Kymanox is now in a position to provide industry-leading human factors solutions to its clients.

Kymanox and Agilis have joined forces to help bring modern medicines to patients faster and with greater accuracy. Through their combined service offerings, clients can now benefit from specialized services and comprehensive usability engineering and human factors studies that will enable successful FDA, EMA, and other regulatory submissions.

Together, the two companies will strive to make biologics, pharmaceuticals, drug/device combinations products, and medical devices available to markets around the world.

With over two decades of experience, Agilis is a leading human factors engineering firm based in Cincinnati, Ohio. We specialize in transforming the drug delivery, medical device, software as a medical device (SaMD) and complex medical technology development process with our unique HFE strategies.

Our early-stage design evaluation and product concept consultation services ensure that products are optimized to meet regulatory requirements while also improving safety, effectiveness and usability. Let us help you cost-effectively design and develop your next medical device.

Agilis Consulting Group has earned a sterling reputation for its ability to provide ‘first time’ success in medical human factors, delivering the highest standards of integrity, agility, and professionalism. As our clients and team began seeking more opportunities and services, it became clear that Kymanox was the ideal partner.

With Kymanox’s diverse team of experts and comprehensive range of services, the synergistic combination of our two companies can meet the ever-increasing demands of the medical device, pharmaceutical, and biologics industries.

The addition of Agilis to Kymanox is a perfect partnership, as the shared values of uncompromising quality and a focus on the end user and patient make it a world-class union. Evan Edwards, Chief Innovation Officer at Kymanox, is proud of the Human Factors and Regulatory Strategy team, led by Quynh Nguyen, for laying the foundation for this opportunity to occur and to provide end-to-end solutions to the life sciences industry.

With Kymanox and Agilis both on board, customers now have access to a reliable and comprehensive service that ensures right-first-time submissions and successful commercialization.

Agilis by Kymanox, the global leader in comprehensive human factors and usability engineering program support, has been making medical devices safer and easier to use for years. With Agilis’ proven human factors processes and regulatory expertise, and Kymanox’s expansive resources, the two companies have come together to create a powerful team that provides strategic advice, guidance and deliverables to ensure right-first-time submissions.

Shannon Hoste, President of Agilis, said, “We are excited to be part of Kymanox and to continue to provide our clients with the highest quality services to ensure the safety and usability of their devices.”

The details of the transaction remain undisclosed, leaving the public to speculate about what may have been negotiated. The mystery surrounding the transaction has sparked intrigue, stirring up conversation among those interested in the outcome.

About Kymanox

Kymanox is a professional services organization that specializes in engineering, scientific, project management, quality, regulatory, human factors, testing/QC, and CQV support for the biotechnology, pharmaceutical, medical device, and combination product industries. Our mission is to empower life science innovation through insightful solutions and collaboration. Our end-to-end solutions help bring life science products to market and keep them there.

Founded in 2004, Kymanox is headquartered in Morrisville, North Carolina and is backed by WestView Capital Partners, a Boston-based growth equity firm. We are proud to help our clients navigate the commercialization challenges that arise throughout a product’s life cycle and are committed to optimizing safety, quality, efficacy, and accessibility.

About Agilis Consulting Group

Agilis Consulting Group is your go-to partner for navigating the complex global regulatory landscape through successful human factors submissions. Our proven strategies, process, and expertise make it possible to bring safe and effective medical devices and combination products to market – the first time. With our help, you can realize your product goals and make a real difference in the global medical market. Trust Agilis to help you get the job done right.

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