From manufacturing through delivery to the patient, pharmaceutical drugs must be maintained within strict temperature guidelines to protect the efficacy of the product. This level of protection is not exclusive to refrigerated and frozen product. Even ambient product (generally 15° C to 25° C) needs protection in climates where it can be at risk of becoming too warm or too cold.
Customs chaos occurs when avoidable errors result in customs delays, preventing on-time delivery of clinical materials to investigator sites. The need to prevent such delays underscores the importance for sponsors of selecting the right importer of record (IOR). This e-book examines the IOR and customs clearance processes.
The transportation of life sciences shipments has become increasingly more complex over the years, with patient pools expanding, often to remote locations across the globe. In addition, the growth of biologics has added increased complexity to the supply chain due to cold chain handling, storage, and distribution requirements across the supply chain.