Yourway

Yourway is an integrated biopharmaceutical supply chain provider for clinical trials, offering primary and secondary clinical packaging, temperature-controlled logistics, storage and distribution to pharmaceutical and biotech companies. From its Allentown, Pennsylvania headquarters and GMP depots on six continents, it packages and labels trial supplies, stores them, sources comparators, and ships drug product and biological samples by premium courier.

Clinical Packaging and Labeling

• Package tablets and capsules into bottles and blisters under GMP, with over-encapsulation for blinding, on automated and semi-automated lines in ISO Class 100,000 primary packaging rooms, from small clinical runs to commercial-scale quantities.
• Provide secondary packaging, including wallet sealing, patient kit design and assembly, and 2–8 °C packaging in a dedicated cold room.
• Label clinical trial materials in house, including time-sensitive labeling, multi-language label design and printing, de-labeling or re-labeling for changes in stability information, and blinding.
• Design packaging around the study's clinical supply strategy, including booklets and label randomization, weighing production volume against cost, temperature sensitivity and transport regulations.

Storage, Sourcing and Release

• Store, manage and distribute clinical materials from GMP-certified depots, with inventory managed through a client portal; depot services include retain samples, retest and expiry labeling, ancillary kits, return drug and destruction.
• Certify batches of sterile and non-sterile products and provide QP services and product release at its EU flagship GMP depot in Dublin.
• Perform QP audits of third-party manufacturing, testing, packaging and labeling facilities, as QP declarations require for imports into the EU.
• Source comparator drugs and ancillary supplies, from laboratory, medical, diagnostic and testing equipment to medical devices and patient education materials, through long-established supplier relationships.

Cold Chain and Premium Courier

• Ship and store temperature-sensitive materials in active and passive temperature-controlled packaging, refrigerated or frozen, and in liquid nitrogen dewars for materials held at –180 °C.
• Serve cell and gene therapy clinical supply chains, with cryogenic shipping and storage.
• Move drug product and biological samples by on-board courier, chartered aircraft, helicopter or temperature-controlled ground transport, with pickup available 24/7.
• Deliver clinical supplies direct to patients' homes in temperature-controlled packaging, and collect and return biological samples, including for patients in remote geographies.
• Manage clinical trial sample logistics, from selecting a compliant laboratory to delivering samples for testing.

Customs and Import Support

• Act as importer of record, clear customs, pay duties on clients' behalf, and prepare commercial invoices and dangerous goods documentation, with a dedicated project manager for each project.

Best Fit

• Sponsors and CROs that want one partner to package, label, store and ship clinical trial supplies worldwide, including temperature-sensitive biologics and cell and gene therapies.