Kymanox
Kymanox specializes in providing comprehensive life science solutions, including design, development, regulatory affairs, and quality assurance for combination products, medical devices, biotechnology, pharmaceuticals, and diagnostics.
Kymanox Services
Kymanox offers a comprehensive array of services tailored to the life sciences industry. Key service areas include design, development, and testing; operations and drug development; facilities and manufacturing; quality and compliance; regulatory affairs; and executive strategy and support. By leveraging their unique Ideal Knowledge Transfer® methodology, Kymanox ensures seamless project management, robust engineering practices, and strategic business acumen.
Kymanox Products and Solutions
Kymanox provides holistic support across the entire product lifecycle, from initial development through to post-market. They specialize in engineering and regulatory services for combination products, medical devices, biotechnology, pharmaceuticals, and diagnostics. Their expertise extends to regulatory submission preparation for various global markets, including IDE, IND, NDA, BLA, 510(k), De-Novo, PMA, CTA, MAA, CE Mark, and NBOp.
Kymanox Design Lab
Located in King of Prussia, PA, the Kymanox Design Lab is equipped with state-of-the-art additive and subtractive manufacturing capabilities, light assembly equipment, and development testing tools. This facility enhances their ability to support innovative design and development projects, ensuring that products meet rigorous standards and are market-ready.
Global Presence of Kymanox
Kymanox operates on a global scale, with offices strategically located in the United States, Switzerland, and Germany. This international presence allows them to provide localized expertise and support, catering to the diverse regulatory and market needs of their global client base. Their widespread footprint ensures that they are well-positioned to assist in market submissions and product registrations across the EU and US.
Kymanox Quality Assurance and Compliance
Kymanox offers comprehensive quality assurance and compliance solutions, including the development and implementation of quality management systems, quality engineering, risk management files, and design history files. Their services ensure that products meet stringent regulatory standards, and they provide support in human factors engineering and usability engineering, particularly for the pharma, biotech, and medical device sectors. Their track record includes assisting clients with 19 successful Pre-Approval Inspections (PAIs).