This comprehensive case study explores Kymanox’s approach to global regulatory compliance and Human Factors (HF) validation through strategic study design and data leveraging across markets. Our team of Subject Matter Experts (SMEs) collaborated closely with pharmaceutical stakeholders to implement measurable improvements across patient labeling optimization, post-market complaint resolution, multi-regional submissions, and combination product development for organizations transitioning from drug-only portfolios.
CHALLENGE
SOLUTION
RESULTS
- Established drug-focused pharmaceutical organization required HF support to successfully branch into combination product development and commercialization.
- Post-market complaitn data for Class II combination product necessitated corrective action across US, EU (MDD), and Candian markets simultaneously.
- Patient labeling (Instructions for Use (IFU)) required optimization for 50+ diverse user groups ensuring safe and effective use.
- Organization lacked prior HF work or internal expertise for combination product regulatory requirements and validation testing.
- Conducted strategic formative evaluation in EU market gathering comprehensive user feedback and identifying optimization opportunities for patient labeling.
- Iterated device design and instructional materials based on EU formative data, submitting regulatory update to European authority demonstrating design improvements.
- Executed US validation study leveraging insights from EU formative work while addressing FDA-specific HF requirements and guidance.
- Further iterated design based on US validation results, submitting regulatory update to FDA ensuring comprehensive use error mitigation.
- Strategically submitted ot Health Canada leveraging combined EU and US validation data maximizing regulatory efficiency across markets.
- Successfully achieved regulatory approval in US, EU, and Canada for improved combination products addressing post-market complaints and safety concerns.
- Obtained New Drug Application (NDA) approval from FDA for combination product demonstrating safe and effective use cross diverse patient populations.
- Strategically leveraged validation study data for second product’s NDA submission, eliminating need for additional HF testing and accelerating FDA approval timeline.
- Established reusable HF data framework supporting organization’s ongoing combination product development strategy.