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™”?

• 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