Kymanox
430 Davis Drive | Suite 300
Morrisville, NC 27560-6802
T: +1 919.246.4896
E: info@kymanox.com
W: www.kymanox.com

Corporate Description

Kymanox is a life science professional services organization that offers engineering, scientific, and compliance support to companies exclusively in the biotechnology, pharmaceutical, medical device, and combination product industries. With its diverse team, Kymanox helps clients navigate commercialization challenges that arise throughout a product’s lifecycle – from early development to post-market commercialization – with optimized safety, quality, efficacy, and accessibility.

Kymanox engineers and scientists, in conjunction with engineers from Neuma by Kymanox, provide end-to-end, integrated support to clients. The combined team helps resolve product design and development challenges, thus more effectively bringing specialized drug delivery and medical device solutions to patients in need.

• Kymanox understands the interaction between devices and drug products. The company’s experience with combination products includes, but is not limited to, injectables, nasal, respiratory, kits, and wearable devices.
• Kymanox transforms innovative and valuable technologies into drug delivery and medical solutions, getting you one step (or many steps) closer to commercial launch.
• Kymanox understands why “the product is the process” and how to implement solutions to unique challenges.
• With drug development constantly evolving with new regulations and technology, Kymanox stays up to date to maintain compliance.

Kymanox serves clients globally from their headquarters in Raleigh (RTP), NC and its offices across the United States. The team consists of more than 200 employees, including over 75 engineers and a well-credentialed contractor network. Kymanox is 100% focused on the life sciences industry with extensive experience across facility, process, and product development. Kymanox offers a number of life science solutions including the following:

Quality, Regulatory, and Compliance Solutions:

• Quality Assurance and Compliance
• Global Quality Auditing
• Quality Engineering
• Quality Control
• Regulatory Affairs
• Clinical & Medical Affairs
• CGxP Microbiology and Environmental Monitoring

Strategy, Planning, and Execution Solutions:

• Program and Project Management
• Technology Transfer
• Staffing Solutions
• Due Diligence
• Innovation Solutions
• Enterprise Resource Planning

Development and Operations Solutions:

• Process Engineering
• MS&T and Supply Chain
• Product and Process Development
• CMC Services and Analytical Sciences
• Packaging Technology and Engineering
• Human Factors Regulatory and Strategy

Commissioning, Qualification, and Validation (CQV) Solutions:

• Process Validation
• Facilities and Utilities CQV
• Cleaning Validation
• Lab and Equipment CQV
• Computer System Validation
• Validation Master Planning

Kymanox partners with you to makes it easier for your life science team to Get More [DONE].