About Kymanox
Kymanox is Your Life Science Solutions Partner. We are a premier technical products and project management company. We are experts in providing our clients in the Biotechnology, Pharmaceutical, and Medical Device, and Combination Product industries with engineering, scientific, regulatory, and process operations support. We help bring products from bench to patient. We differentiate ourselves by offering a broad range of technical services and products with turnkey project delivery. We serve clients globally from our headquarters in Durham (RTP), North Carolina and branch hubs across the US.
Kymanox is Your Life Science Solutions Partner. We are a premier technical products and project management company. We are experts in providing our clients in the Biotechnology, Pharmaceutical, and Medical Device, and Combination Product industries with engineering, scientific, regulatory, and process operations support. We help bring products from bench to patient. We differentiate ourselves by offering a broad range of technical services and products with turnkey project delivery. We serve clients globally from our headquarters in Durham (RTP), North Carolina and branch hubs across the US.
Kymanox was founded in 2004 in Highland Park, Illinois, USA. After serving in the Life Science industry for many years, Stephen M. Perry decided to put his knowledge and resources into his own company. Understanding that manufacturers, and the like, need technical assistance, Mr. Perry set out to partner with drug, biologic, combination product, and medical device makers to bring their products from bench to patient better, faster, and more affordable. By 2008, Kymanox’s Headquarters were relocated to RTP, North Carolina and the Illinois office formed the company’s first hub. Kymanox’s team continues to grow and help clients around the world GET MORE DONE!
The company’s network of SMEs is far-reaching and includes those at our hubs throughout the nation. Kymanox currently has hubs in Alpharetta GA, Huntsville AL, Seattle WA, Boston MA, and Chicago IL. From these hubs and our headquarters in Research Triangle Park NC, we serve clients globally and GET MORE DONE.
Throughout the growth of the company, IDEAL KNOWLEDGE TRANSFER™ has remained the focus. Knowledge transfer is akin to teaching and learning with a predetermined end-goal in mind. When know-how, expertise or technology moves from one place or person to another, knowledge transfer is taking place. Our teams are fixated on this process and utilize it in each of our projects, guaranteeing you best-in-class service.
The company name, Kymanox (pronounced ki’-mah-noks’), is derived from the words kyma and gnosi. In Greek, kyma means “wave” and gnosi means “knowledge.” Waves, visible and invisible, are ubiquitous in our environment at both large and small scales; they transport energy and matter with unmatched efficiency. Therefore, waves symbolically represent ideal transfer. The name Kymanox means “ideal knowledge transfer.” The company logo is an artistic rendering of a wave within a humanesque sphere.
Kymanox was founded in 2004 in Highland Park, Illinois, USA. After serving in the Life Science industry for many years, Stephen M. Perry decided to put his knowledge and resources into his own company. Understanding that manufacturers, and the like, need technical assistance, Mr. Perry set out to partner with drug, biologic, combination product, and medical device makers to bring their products from bench to patient better, faster, and more affordable. By 2008, Kymanox’s Headquarters were relocated to RTP, North Carolina and the Illinois office formed the company’s first hub. Kymanox’s team continues to grow and help clients around the world GET MORE DONE!
The company’s network of SMEs is far-reaching and includes those at our hubs throughout the nation. Kymanox currently has hubs in Alpharetta GA, Huntsville AL, Seattle WA, Boston MA, and Chicago IL. From these hubs and our headquarters in Research Triangle Park NC, we serve clients globally and GET MORE DONE.
Throughout the growth of the company, IDEAL KNOWLEDGE TRANSFER™ has remained the focus. Knowledge transfer is akin to teaching and learning with a predetermined end-goal in mind. When know-how, expertise or technology moves from one place or person to another, knowledge transfer is taking place. Our teams are fixated on this process and utilize it in each of our projects, guaranteeing you best-in-class service.
The company name, Kymanox (pronounced ki’-mah-noks’), is derived from the words kyma and gnosi. In Greek, kyma means “wave” and gnosi means “knowledge.” Waves, visible and invisible, are ubiquitous in our environment at both large and small scales; they transport energy and matter with unmatched efficiency. Therefore, waves symbolically represent ideal transfer. The name Kymanox means “ideal knowledge transfer.” The company logo is an artistic rendering of a wave within a humanesque sphere.
Kymanox Services
- Our Ideal Knowledge Transfer™ (IKT™) helps organizations achieve predictable project success
- Develop and maintain Project Management Office (PMO) policies, procedures, and templates
- Advanced reporting tools communicate scope, schedule, budget, and risk to ensure projects stay on track (e.g., project dashboards, KPIs)
- Execution-focused methodology
- Planning and risk management employed early to avoid costly and often irreversible missteps
- Working meetings have pre-published agendas, detailed meeting minutes, and tracked action items and decisions
- Process Engineering, Manufacturing Science, Technical Services, Analytical Sciences, and Product Development
- Industry leading Tech Transfer Toolkit™ reliably links Development and Manufacturing
- Aligned with principles of Quality by Design (QbD) and integration of professional project management methodologies
- 360° view and orthogonal approach: - Process-Centric - Statistics and Data Analytics - Proactive Measures and Remediation - Full Lifecycle Management - Training
- CGMP Commissioning, Qualification, and Validation (CQV) leveraging requirements documentation and risk management
- Proven past performance includes facilities, utilities, equipment, Computer System Validation (CSV)/Part 11, methods, processes, and cleaning
- Best-in-class documents stand as monuments for compliance and your business
- Extensive design experience means we understand what we are validating
- Specialty CSV and Part 11 compliance for Enterprise Resource Planning (ERP) systems (e.g., SAP)
- Our experts eliminate ambiguity surrounding regulations and published guidance to make end requirements clear and concise
- Quality and Regulatory support for biotech, pharma, medical device, in vitro diagnostic devices (IVD), and combination products
- Regulatory submission project management, authoring, and review
- Turnkey Pre-Approval Inspection (PAI) readiness
- Full Quality Management System (QMS) development and implementation
- Regulatory body responses and remediation
- Audit program oversight and execution
- Quality engineering support for medical devices and combination products
Biotechnology | Pharmaceuticals | Medical Devices | Combination Products