In the EU, Investigational Medicinal Products (IMPs) cannot be released to clinical trial sites until the batch has been certified by a Qualified Person (QP). There are various different types of batch release depending on where the product has been manufactured.
Xerimis offers storage of clinical supplies under qualified, temperature controlled conditions for clinical trials. We have capabilities for storing clinical supplies under controlled room temperature, refrigerated, frozen and ultra low frozen conditions.
Your solution for clinical supply management
Clinical trial sponsors face complex decisions related to product development. For our clients, packaging isn’t one of them. We’ve overseen packaging for thousands of clinical trials worldwide. Our insights, gained through years of experience, produce optimal outcomes aligned with trial objectives and applicable regulations.
Our labeling and packaging expertise is met with a true understanding of the ever-changing needs of our clients. We understand timelines, last minute changes, and work to be a nimble partner.
We help our clients navigate regulatory requirements ensuring accuracy, compliance and proper documentation. We prepare receipts of returns, accountability reports, and destruction verification reports according to your specification.
Successful trials hinge on well-planned logistics. Our global distribution managers work with clients to establish, plan, and manage shipment schedules and strategies.