Technology Transfer
The PBC Biomed Headquarters in Shannon is an ISO 13485 accredited facility, with clean rooms and labs. We can support GMP manufacturing at development scale on account of our vast experience in this area, as well as our tried-and-trusted procedures. We have an dedicated Program Management team in addition to our engineers and scientists, who support our Technology Transfer programme and ensure that timelines and milestones are met.
Contract Manufacturing
We have strong expertise and a range of capabilities across multiple areas of manufacturing, including Lyophilisation, Coating, Additive Manufacturing and 3D Printing. Our ISO 13485 facility and ISO 9001 certified processes enables us to perform cleanroom manufacturing, as well as manage the packing and sterilisation for a range of medical device products.
Distribution
At PBC Biomed we know that it is critical that patients from all geographical areas have access to the newest medical technologies. We provide access to the European marketplace and beyond for supply chain requirements, including storage, packaging and shipping. We can also facilitate access to all global freight forwarders.
Quality Management
Our team of experts can assist with a full spectrum of QMS support. We can offer programs on; documentation implementation & management, internal auditing, design control, risk management for design, supplier auditing, process validation programs, as well as training and external audit support. We also offer gap assessments against various international standards, such as ISO 13485:2016, ISO 9001:2015 and FDA CFR Chapter 21 820.