Capabilities
Newsol PD offers integrated CDMO services in the areas of GMP manufacturing, development, and regulatory support for sterile dialysis and infusion solutions.
Production
GMP-compliant manufacturing of sterile dialysis and infusion solutions, including:
- Standard solutions for peritoneal dialysis
- Bicarbonate-based dialysis formulations
- Multi-chamber solution bag systems
- Customized sterile solutions
Production activities are designed for both clinical supply and commercial manufacturing.
Development
Technical support for the development and implementation of customized dialysis and infusion products, including:
- Formulation development for sterile solutions
- Design of dialysis bags, connectology, and system components
- Integration into medical devices
- Process development and scale-up
Quality and Regulatory
Newsol PD is committed to establishing and maintaining quality and regulatory systems in accordance with internationally recognized standards.
The company’s quality framework is developed in compliance with EU GMP requirements for sterile pharmaceutical manufacturing.
Quality management, documentation, and process control are designed to ensure consistent product quality and regulatory compliance across all stages of development and production.
Added Value for Partners
Through its integrated CDMO capabilities, Newsol PD supports partners in addressing key challenges in sterile pharmaceutical manufacturing and dialysis solution production.
This includes:
- Enabling GMP manufacturing without requiring own infrastructure
- Supporting an efficient transition from development to commercial production
- Reducing technical and regulatory complexity in product development
- Providing flexibility in terms of production scale and product configuration