Clinical and Commercial Packaging & Labeling

Alcami provides custom packaging, labeling, and kitting for clinical trial materials destined for trials around the world.

We also provide specialized expert support for randomization and blinding studies, including placebo, comparator, and crossover studies, as well as reconciliation drug accountability, serialization, and destruction services as needed. With the ability to accommodate preclinical through commercial lifecycles, our inherent flexibility allows clients direct access to a simplified supply chain. Alcami offers stand-alone pharmaceutical packaging through full development programs that can be integrated with manufacturing, stability storage, and analytical services. 

We have made significant investments to upgrade our packaging lines for full serialization and aggregation capability. Partnering with TraceLink® to launch an enterprise-level serial number management system, through TraceLink® Life Sciences Cloud, has enabled us to have serial number generation and commissioning as well as data transfer with our clients and trading partners. Our serial number management system has the flexibility to integrate with other solutions and supports various serial number provisioning models

Core Capabilities: Labeling & Packaging 

  • First-In-Human (FIH) to commercial

  • Solid dose bottling (30cc to 500cc round)

  • Cold form and thermoform blistering lines

  • Vial labeling and semi-automated secondary packaging (vial size 2 - 50mL)

  • Pre-filled syringe labeling

  • Multi-lingual labeling

  • Open and blinded labels and randomization

  • Manual packaging and clinical kitting

  • Serialization with three or four levels of aggregation available

  • Temperature controlled and humidity monitored warehouse

  • Global distribution with QP release into the EU

  • Cold chain capable

  • Proven regulatory track record

  • DEA schedule I-V

Packaging & Labeling
 

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