Kymanox
Kymanox is a global life sciences professional services organization dedicated to accelerating the development, regulatory approval, and commercialization of medicines, medical devices, and combination products. With over 20 years of experience and more than 2000 projects completed, Kymanox offers comprehensive engineering, scientific, regulatory, and project management support to help clients bring innovative healthcare solutions to market efficiently and safely. The company emphasizes 'Ideal Knowledge Transfer™' to ensure seamless collaboration and high-quality outcomes, supporting clients from early development through post-market activities.
Industries
Nr. of Employees
large (251-1000)
Products
Executive Support & Strategy
Provides program and project management, executive advisory, due diligence, staffing, and a hyper-virtual model for operational support.
Design, Development, & Testing
Covers product and process development, human factors engineering, design control and risk management, test engineering, design and innovation services, and formulation engineering.
Quality & Compliance
Includes quality assurance, audit and PAI readiness, clinical and medical support, post-market surveillance, complaint management, and regulatory affairs.
Facilities & Manufacturing
Offers automation, facility/utility engineering, validation (CQV), ERP and computer system validation (CSV), and packaging technology and engineering.
Technical Operations
Encompasses CMC, process engineering, microbiology and analytical sciences, MS&T, supply chain and logistics, and tech transfer.
Regulatory Affairs
Provides advisory services, regulatory submissions, and regulatory body interactions.
Executive Support & Strategy
Provides program and project management, executive advisory, due diligence, staffing, and a hyper-virtual model for operational support.
Design, Development, & Testing
Covers product and process development, human factors engineering, design control and risk management, test engineering, design and innovation services, and formulation engineering.
Quality & Compliance
Includes quality assurance, audit and PAI readiness, clinical and medical support, post-market surveillance, complaint management, and regulatory affairs.
Facilities & Manufacturing
Offers automation, facility/utility engineering, validation (CQV), ERP and computer system validation (CSV), and packaging technology and engineering.
Technical Operations
Encompasses CMC, process engineering, microbiology and analytical sciences, MS&T, supply chain and logistics, and tech transfer.
Regulatory Affairs
Provides advisory services, regulatory submissions, and regulatory body interactions.
Services
Product concepting, CAD design, prototyping, subsystem engineering, failure analysis, and design documentation to support verification, validation, and regulatory submission.
Turnkey laboratory services including test method development, equipment qualification, execution of verification and validation testing, and data analysis reporting in a CGxP environment.
Regulatory assessments, submission planning and authorship, and market-entry strategy for US and EU jurisdictions, including advice on clinical bridging and CE/FDA pathways.
QMS documentation development, gap assessments, training content, audit and remediation support, and quality-event management (CAPA, investigations, complaints).
Sterilization feasibility assessments, development of sterilization validation protocols (IQ/OQ/PQ), selection of biological indicators and process challenge devices, and sterile packaging qualification.
Design and engineering of cleanrooms, HVAC capacity planning, electrical and process flow design, and validation lifecycle support for cleanrooms, laminar flow hoods, and biosafety cabinets.
Product concepting, CAD design, prototyping, subsystem engineering, failure analysis, and design documentation to support verification, validation, and regulatory submission.
Turnkey laboratory services including test method development, equipment qualification, execution of verification and validation testing, and data analysis reporting in a CGxP environment.
Regulatory assessments, submission planning and authorship, and market-entry strategy for US and EU jurisdictions, including advice on clinical bridging and CE/FDA pathways.
QMS documentation development, gap assessments, training content, audit and remediation support, and quality-event management (CAPA, investigations, complaints).
Sterilization feasibility assessments, development of sterilization validation protocols (IQ/OQ/PQ), selection of biological indicators and process challenge devices, and sterile packaging qualification.
Design and engineering of cleanrooms, HVAC capacity planning, electrical and process flow design, and validation lifecycle support for cleanrooms, laminar flow hoods, and biosafety cabinets.
Expertise Areas
- Combination product development
- Medical device design and verification
- Pharmaceutical development and CMC
- Biotechnology and cell & gene therapy support
Key Technologies
- CAD and rapid prototyping (3D printing, machining)
- Universal testing machines and mechanical test methods
- Solid modeling (e.g., SolidWorks)
- Statistical analysis and DOE (Minitab, SPC)
News & Updates
Kymanox was recognized as the 4th fastest growing private company in the Triangle region, highlighting its significant growth and impact in the life sciences industry.
An article discussing strategies for clinical bridging in combination drug products, emphasizing risk-based approaches.
Recognized as one of the fastest-growing private companies in the Triangle region, reflecting strong business growth and industry impact.
Kymanox was recognized as the 4th fastest growing private company in the Triangle region, highlighting its significant growth and impact in the life sciences industry.
An article discussing strategies for clinical bridging in combination drug products, emphasizing risk-based approaches.
Recognized as one of the fastest-growing private companies in the Triangle region, reflecting strong business growth and industry impact.