Solutions Library
Kymanox promises to help you GET MORE DONE.
We utilize our broad range of technical services and products to provide you with relevant solutions.
- 3 Assay Development Rules for Tech Transfer
- Better Technology Transfer for Faster Growth
- Facility Startup
- FAT / SAT Support
- Good Documentation Practices
- Good Manufacturing Practices (GMP)
- Good Writing Guidelines
- Kymanox Project Management Course
- PAI Preparation and Remediation
- Process Development
- Technical Project Management
- What is the Kymanox “Ideal Knowledge Transfer™”?
- 3 Assay Development Rules for Tech Transfer
- Aseptic Fill Lines
- Aseptic Manufacturing
- Autoclaves and Sterilization
- Better Technology Transfer for Faster Growth
- Cleanrooms and Hoods Engineering
- Facility Startup
- FAT / SAT Support
- Gap and Risk Assessments
- GMP Facility Design
- Good Documentation Practices
- Good Manufacturing Practices (GMP)
- Good Writing Guidelines
- Kymanox Project Management Course
- Mechanical Integrity
- Medical Device Design
- Medical Device Design Controls
- PAI Preparation and Remediation
- Process Development
- Process Equipment Procurement
- Process Optimization
- Process Troubleshooting
- Risk Evaluation and Mitigation Strategies (REMS)
- What is the Kymanox “Ideal Knowledge Transfer™”?
- 3 Assay Development Rules for Tech Transfer
- Better Technology Transfer for Faster Growth
- Clean Utilities Engineering
- Cleaning Validation
- Facility Startup
- Facility, Utility, and Equipment Qualification
- FAT / SAT Support
- GAMP 5 – URS/FRS
- Good Documentation Practices
- Good Manufacturing Practices (GMP)
- Good Writing Guidelines
- PAI Preparation and Remediation
- Process Validation
- Validation Equipment Rental
- What is the Kymanox “Ideal Knowledge Transfer™”?
- 503B Outsourcing Facilities
- Combination Product Compliance
- Complaint Management
- Corrective and Preventive Action (CAPA)
- CSV & Part 11 Compliance
- Data Integrity
- Data Logging & Mapping
- Detailed Product and Process Description (DPPD)
- Device Design Dossier, History and Technical Files
- Facility Startup
- FAT / SAT Support
- Form FDA-483s and Warning Letters
- Gap and Risk Assessments
- Global Audit Support
- GMP Training
- Good Clinical Practice Compliance Solutions
- Good Documentation Practices
- Good Manufacturing Practices (GMP)
- Good Writing Guidelines
- Item Specifications
- Materials Management
- Medical Device Design Controls
- PAI Preparation and Remediation
- Performing Investigations
- Policy, SOP, and Form Development
- Quality by Design
- Quality Management System Development
- Quality Management Systems
- Quality Risk Management
- Risk Evaluation and Mitigation Strategies (REMS)
- SAP / ERP – FDA Compliance
- Six Mistakes Made in a CGxP Quality Audit and How Kymanox Avoids Them
Biotechnology | Pharmaceuticals | Medical Devices | Combination Products