This specialized case study explores Kymanox’s approach to EU regulatory navigation and combination product development through strategic consultation and technical documentation excellence. Our team of Subject Matter Experts (SMEs) collaborated closely with pharmaceutical stakeholders to implement measurable improvements across Quality Management System (QMS) expansion, Notified Body (NB) selection, technical documentation, and General Safety & Performance Requirements (GSPR) for Prefilled Syringe (PFS) format development.
CHALLENGE
SOLUTION
RESULTS
- Pharmaceutical client required EU regulatory support to obtain market authorization for PFS format of existing commercial therapy already available in vial/syringe presentation.
- Comprehensive combination product expertise needed across technical development, quality systems, and regulatory affairs to navigate complex EU requirements.
- QMS expansion essential to incorporate combination product-specific processes, procedures, and documentation standards.
- Strategic NB selection and engagement critical to achieving timey market authorization and successful commercial launch in European markets.
- Provided comprehensive project management and strategic regulatory support to client project team ensuring alignment with EU Medical Device Regulation (EU MDR) requirements.
- Expanded and enhanced QMS incorporating combination product-related process, procedures, and documentation standards meeting EU MDR expectations.
- Created comprehensive technical documentation supporting regulatory submissions and demonstrating product safety, performance, and quality throughout development lifecycle.
- Led product development activities coordinating cross-functional teams and ensuring regulatory compliance at each development phase.
- Developed detailed GSPR checklist and strategically identified appropriate NB for obtaining opinion supporting marketing authorization application.
- Successfully obtained positive Notified Body Opinion (NBO) on first submission enabling market authorization approval in 2022 without delays or major deficiencies.
- Achieved efficient EU regulatory pathway for PFS format expanding commercial therapy availabiltiy and patient convenience.
- established robust combination product quality management framework supporting ongoing compliance and future product development initiaitives.
- Delivered streamlined regulatory strategy minimizing time-to-market and development costs while ensuring full compliance with stringent EU requirements.