Contract Manufacturing of Drug Delivery Devices

Your contract manufacturing partner of drug delivery devices

We offer a broad range of manufacturing services and capabilities to produce high-quality devices including pen injectors, auto-injectors, and on-body delivery systems.

In addition, we work on specialty devices in drug delivery that require expertise in areas such as Molding, Tooling, Assembly, and more.

Design & Development

• We have extensive experience in Design for Manufacturing (DfM) and Design for Assembly (DfA) for production at different volumes
• Our R&D staff work closely with our clients backed by a sound network of development and testing partners, as well as consulting experts where needed
• We offer mechanical and functional testing, complex math modeling, risk management, usability studies, and verification support

Tooling

• Established partnerships with leading tool producers and in-house expertise in tool design & maintenance to prolong the life of your tooling and to ensure that the right tooling solution is provided
• Experience with a range of tooling, from low to high cavitation solutions that suit our client needs
• Tool maintenance programs and availability of spare parts are available to minimize production downtime

Quality, Regulatory & Operational Excellence

• Quality Management System according to ISO 15378, ISO 13485 and 21CFR820 (for our US operations)
• FDA inspected site (Germany)
• State-of-the-art measuring technologies with computer tomography, tactile and optical measurements
• Risk-based qualification and validation (DQ, IQ, OQ, PQ)
• Offering bio-compatibility study support, shipping validation and stability testing
• Worldwide product registration experience
• Six-Sigma approach throughout the entire industrial product life cycle

Global supply chain

• Global purchasing network
• Global logistics expertise