Kymanox Acquires Agilis Consulting Group, a Trusted Human Factors…

Kymanox Acquires Agilis Consulting Group, a Trusted Human Factors…

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MORRISVILLE, N.C., and Cincinnati, Ohio, March 24, 2023 (GLOBE NEWSWIRE) — Kymanox Corporation (“Kymanox”), a professional services company serving exclusively the life sciences industry, today announced the acquisition of Agilis Advisory Group. Agilis is a trusted Human Factors partner for the global medical market. They specialize in helping new and established companies achieve successful HF filings while navigating the complex global regulatory landscape resulting in safe and effective medical products being brought to market.

Kymanox’s acquisition of Agilis helps both companies achieve their shared corporate goal of bringing modern medicines to patients while strengthening their service capabilities by providing customers with a broader range of highly specialized services. Comprehensive usability engineering and HF study support will help ensure successful FDA, EMA and other regulatory submissions. The strength of the combined companies’ service offerings and expertise will benefit customers bringing to market important biologics, including biosimilars and cell and gene therapies (C>s), pharmaceuticals, drug/device combination products and medical devices worldwide.

Based in Cincinnati, Ohio, Agilis has been successfully navigating the Human Factors Engineering (HFE) process for drug delivery devices, medical devices, SaMD products and complex medical technologies for over two decades. Agilis provides early design assessment and product concept advice for a wide range of products in a variety of therapeutic areas to improve in-use safety, efficacy and overall usability. Their proprietary HFE strategies aim to cost-effectively optimize device design to meet regulatory requirements.

“For more than 20 years, the Agilis Consulting Group has been distinguished by its ability to achieve first-time regulatory success in medical human factors, done with integrity, agility and…

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