Clinical and Commercial Manufacturing

We leverage our long-standing experience and proven approach to deliver leading global manufacturing solutions for drug delivery devices. Leaders in the industry trust us to manufacture their most valuable device platforms. With meticulous diligence, we define and implement the ideal process and industrial approach to ensure control, quality, safety, and effectiveness are integrated into your commercial manufacturing. We can also expediate your clinical trial process with fit for purpose clinical device supply. Our global expertise enables timely, high-quality, and safe supply, tailored to your custom requirements. Partner with us for unparalleled manufacturing expertise that ensures exceptional results throughout your device’s journey.

cGMP Clinical Supply – Accelerating time to clinical trials

We can deliver high-quality clinical devices efficiently, helping you expedite your path to clinical trials. Our streamlined manufacturing processes and optimized efficiency ensure the timely supply devices. Our new site in Poland has specialized expertise in small series and fit for purpose supply. With our expertise, we proactively address potential bottlenecks, supporting your research progress and bringing innovations to market faster.

Process Definition and Manufacturing Planning – Custom solutions for your product

Through close collaboration with your team, our team defines the manufacturing process for your devices. We consider critical steps and parameters, developing comprehensive manufacturing plans to achieve optimal outcomes. By meticulously planning and documenting the process, we ensure consistency, efficiency, and traceability throughout production. We believe it is critical to consider the entire combination product when scaled to a commercial-level combination product and that early planning is critical to ensure seamless progression through development and industrialization phases and identification of the ideal manufacturing location for your device.

Global Small Series and High-Scale Manufacturing – Flexible solutions for your manufacturing footprint

Our manufacturing facilities in Europe and North America are equipped to manage various production volumes with precision and efficiency. Our specialty is high-precision injection molding and assembly. Whether you require small-scale production or high-scale manufacturing, we have the capacity and expertise to meet your needs. We also are focused on sustainability through energy efficiency, material selection to minimize waste and increasing reliability throughout the process. With a focus on quality, scalability, and timely delivery we ensure your devices are manufactured to the highest standards increasing reliability throughout the process.

Lifecycle Management – Extending the value of your device and assets

We consider the lifecycle management of your product an essential part of our ongoing relationship. Collaborating with you, we develop a post-launch roadmap that provides a clear overview of all post-launch activities. While maintaining the viability of your production assets, the roadmap continually focuses on improving quality, sustainability,  reducing costs, and adding utility beyond the launch. We can also assist you on collecting and analyzing post market release data and contemplate improvements to your device in future generations.