SERVICES
WHAT WE DO
At Kymanox, we provide a very broad range of services. Our clients find this useful since they can go to Kymanox for a great majority of their needs - thus minimizing the number of contract firms to manage with their organization. We have over 50 pre-approved team members many of which hold PhDs and advanced certifications such as PE, PMP, MBA, and so on. Using our team approach, we can provide optimized and vetted recommendations with the ability to execute the selected recommendation. For a summary of our experience, click here.
- Thought leaders in technology transfer best practices
- Integrated project management approach
- Cost, timeline, and risk mitigation
- Scientific & engineering expertise in scale-up
- Focus on commercialization in regulated environments
- Best-in-class documentation to ensure knowledge transfer
- QbD & Risk Management approach
- IND, NDA, BLA, PMA, & 510k submissions
- Biotech, Pharma, & Device gap assessments
- Inspections, Audits & PAIs
- CMC, Viral Clearance, & Technology Transfer specialists
- US Agent representation - fluent in Japanese & Chinese
- Multidisciplinary teams & professional PM approach
- Documentation proven to withstand FDA & EMA scrutiny
- Access to world-class templates on KymaSTORE
- Validation specialties:
- Process - Cleaning
- Assay/Method - Equipment
- Facility - Computer System
