The Kymanox Analytical Sciences group has professionals with global experience in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide ongoing support for all phases of development, from discovery to post-commercialization. With a comprehensive library of proven templates covering study design through final reporting, we meet required timelines and maximize effectiveness and efficiency.

Kymanox provides support in the following areas:

• Analytical Method Characterization, Development, and Validation

• Laboratory Equipment and Instrument Qualification

• Cleaning Method Development and Disinfectant Efficacy

• Formulation and Process Development and Optimization

• Microbiological Identification and Method Validation

• Stability Program Development and Oversight

• Advanced Statistical Data Analysis

• Turnkey Documentation Development

• Remediation Support for CGMP Inspection Observations

• PAI Support of Analytical Laboratories and GLP Inspections

• Design and Setup of CGMP and GLP Analytical Laboratories

• Quality Operations Support

Kymanox holds a 360° view of all operations and augments our analytical sciences services with additional capabilities:

• Validation and Process Engineering

• Project Management and Training

• Quality Assurance, Quality Control, and Regulatory Compliance

Integrating our science, engineering, quality, and compliance capabilities, Kymanox helps you avoid costly and often irreversible missteps. Together with you, Kymanox helps select optimal procedures, methods, and equipment to develop effective and controlled analytical science programs from early product development through commercial manufacturing.

Biotechnology | Pharmaceuticals | Medical Devices | Combination Products