Our Services

Project Managment LabelKymanox PMO resources have the capability to manage both small (10-100K USD) and large CGXP projects (10-100MM USD). Kymanox PMs ensure objectives are met by controlling, documenting, and communicating scope, schedule, budget, and risks.
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Process Ops Label
Our multi-disciplinary engineers are experts at Process Engineering and Manufacturing Science. Our proven past performance includes facility conceptual design, scale-up and tech transfer, commercial start-up, troubleshooting, surveillance, and optimization.
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Validation Label
Our Validation Team knows that the key to successful validation is having clear, robust requirements and detailed commissioning. We provide turnkey DQ/IQ/OQ/PQ support for equipment, facilities, utilities, processes, methods, and computer systems.
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Q+C Label
At Kymanox, we provide comprehensive Quality Assurance and Regulatory Compliance services for biologics, pharmaceuticals, medical devices, and combination products. Our experienced and talented team provides solutions that are Right First Time (RFT).
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Our Latest Updates

-Keeping Up with Device Record Requirements- In order to market a medical device in the United States or the European Union (as well as other regions of the world), a manufacturer must comply with the regulatory body requirements concerning the files and records necessary to prove that a medical device was designed and developed in… Read More

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-Manufacturing GMP Facility Design- Kymanox has been designing GMP facilities since its inception. We provide upfront facility design layouts and partner with other engineering firms to produce facility permit drawings. In addition, we offer assistance with facility location selection. Kymanox have produced the conceptual designs for a wide range of GMP manufacturing buildings: Pharmaceutical (Solid… Read More

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-Risk Based Inspection- Pharmaceutical and biotech production facilities, and the processing equipment are aging, with many systems aging beyond 20 years. Manufacturers are now beginning to experience problems associated with aging, and are having to develop strategies to respond to the approaching equipment end of lifetime. Traditionally, manual inspections are used to detect potential issues… Read More

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Testimonials

What Our Customers Think

Projects managed by Kymanox run more smoothly and tend to get done faster than the projects we run internally (just using Kymanox staff).

I didn’t have to do anything to the documentation Kymanox prepared for me. It was excellent.

If all my project teams were as easy to work with as this one, I’d have less gray hair!

Could not do it without you and I mean it from the bottom of my heart.