This comprehensive case study explores Kymanox’s approach to Prefilled Syringe (PFS) development and regulatory approval through end-to-end technical and compliance solutions. Our team of Subjects Matter Experts (SMEs) collaborated closely with stakeholders to implement measurable improvement across device selection, supplier management, technical documentation, and regulatory submissions for biosimilar PFS products is US and EU markets.
CHALLENGE
SOLUTION
RESULTS
- Pharmaceutical clients required extensive experience with PFS products supporting development, testing, and successful registration in US and EU markets.
- Broad technical support needed in PFS development, including consultation, design control processes, and compilation and submission of regulatory dossiers.
- Expert guidance required for biosimilar product development meeting stringent combination product requirements.
- End-to-end project management essential for seamless regulatory approval.
- Delivered complete end-to-end development of PFS biosimilar product from concept through regulatory submissions.
- Led selection of alternative Needle Safety Device (NSD) with competitive market advantages and enhanced patient safety features.
- Managed supplier relationships, conducted comprehensive audits, and ensured quality standards across manufacturing partners.
- Generated technical documentation in TachysCP platform in accordance with combination product regulatory requirements.
- Coordinated dossier submission and served as liaison with Notified Body (NB) throughout approval process.
- Provided critical technical support including gap analysis, risk management assessments, Quality Management System (QMS) development, and Standard Operating Procedure (SOP) generation.
- Successfully developed and registered PFS biosimilar products in both US and EU markets.
- Implemented competitively advantageous NSD improving market positioning and patient safety.
- Achieved regulatory submissions through comprehensive technical documentation and effective NB collaboration.
- Established robust QMS and SOPs ensuring ongoing compliance and operational excellence.