This specialized case study explores Kymanox’s approach to performing a comprehensive regulatory and quality gap assessment for a novel inhaler development program. Our team of SMEs collaborated closely with stakeholders to implement measurable improvements across human factors, design controls, and Contract Manufacturing Organization (CMO) selection, ensuring regulatory alignment and clinical trial readiness.
CHALLENGE
SOLUTION
RESULTS
- Conduct comprehensive gap assessments aligned with industry and regulatory standards for key HF activities, Design History Files (DHF), and Quality Management Systems (QMS).
- Ensure compliance with combination product and device design control regulations.
- Assist in selecting the optimal inhaler technology and CMO for Phase II clinical trials due to limited in-house expertise.
- Delivered subject matter expertise with FDA experience in HF, ensuring assessments met design control and quality system regulations.
- Developed targeted gap assessments with prioritized, actionable recommendations addressing HF testing, initial design documentation, and critical quality procedures.
- Evaluated available Dry Powder Inhaler (DPI) technologies in a comprehensive landscape assessment.
- Identified CMOs for best fit for Phase II trials of two (2) drug products.
- Provided the client with clear, actionable guidance to address regulatory gaps, boosting confidence in their procedures and documentation.
- Enabled effective remediation of critical gaps to improve compliance with regulatory expectations.
- Supported successful selection of inhaler technology and CMO, streamlining preparation for clinical trial execution.