Kymanox Capabilities
The Kymanox Quality Control (QC) team provides knowledge and expertise to ensure that you align your practices to the revised European Union (EU) GMP Annex 1, a guidance document for the manufacture of sterile medicinal products.
Meet our Quality Control Experts
Jaime Rain, MMB
DIRECTOR, QUALITY CONTROL




Helpful Links
Here are some of our favorite resources on this topic
Markets That Benefit from Our Quality Control Solutions
Combination Products
Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.
Biologics & Cell and Gene Therapy Services
We understand why “the product is the process” and how to implement solutions to your unique challenges.




The Kymanox Quality Control Difference
We ensure your Quality Control needs are not only right for your company but also aligned with regulatory expectations by blending our hands-on, practical quality control experience with other functional capabilities.

"Right First Time” Execution
Our branded methodology, Ideal Knowledge TransferTM, combines technical project management, fundamental engineering practices, quality and regulatory expertise, and business acumen.

Proven Broad Expertise
Our team of experts is focused on life sciences with extensive experience across drug and device development. No matter your challenge, we can help you conquer it.

Flexibility & Agility
At Kymanox, we make it easy for clients to get the solutions they need, when they need it. Clients tell us our flexibility is one of the key reasons they keep coming back.
Read the Latest at Kymanox
The Factor Podcast: Winning Formula to Navigate Combination Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. Susan Neadle recently penned the highly anticipated "Combination Products Handbook," a practical guide that collects her years of industry experience into a compr...
The Factor Podcast: Transforming Nursing Through Innovation and The Evolving Role of Nurses in Advancing Patient-Centered Care
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, we speak with industry leader, Dr. Bonnie Clipper, to discuss innovations in technologies to empower nurses and improve patient care. Dr. Bonnie C...
The Factor Podcast: Exploring EUDAMED Requirements for EU MDR
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this informative episode of The Factor, we sit down with industry experts, Dr. Christiana Hofmann and Richard Houlihan, to discuss EU MDR's implementa...