In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
Analyze some common causes of medical and pharmaceutical spelling errors and what can be done to eradicate them.
Changing and creating documentation involves many disciplines and long lead times. This case study explains how to improve Global Documentation Change Control Processes quickly and easily.
When customers consolidate their supply chain and use one vendor from drug substance through drug product, it can transform the entire drug development process into a more efficient system.
Blood products continue to increase in cost, and loss of product due to logistical issues, transportation equipment failure, or other transport difficulties can create not only financial problems, but also impact costs measured in human lives. However, using the appropriate cold chain solutions can help address many of the issues related to storage and transportation of blood products.
Rapid growth and geographic expansion in the biopharmaceutical market is increasing supply chain risks that need to be well understood.
Learn more about how free trade zones can offer cost-efficient ways to manage your clinical trial.
See how this service can benefit you with shorter lead time, less waste, less stock out risk and no booklet labels.
CSafe Global announces a significant strategic growth milestone with the manufacture of the 1000th RKN active container. This accomplishment is a testament to the dedication of our manufacturing, customer service, technical support and sales team as we continue to meet the increasing demand from biopharmaceutical companies for the CSafe RKN.
Get the performance, Peace of Mind®, and cost savings you’ve been looking for with CSafe’s AcuTemp® brand passive packaging. Our passive solutions are engineered around the superior thermal attributes of CSafe’s ThermoCor® VIP and are designed and tested to maintain specific temperature range and duration. The passive solutions assortment includes packaging for 2-8°C, CRT and frozen with hold times up to 240 hours and payload volumes up to 50 liters.
Biopharma product shipments can save and improve lives and have positive impacts on entire communities - but only if they arrive safe, stable, and effective.
GlobalVision inspects barcodes directly in the software, so you don’t need to verify them with a device. It’s barcode checking and barcode validation made easy.
The stages below illustrate an excellent starting point for planning your serialization program, but should not be considered all inclusive. As with any program, the emphasis is on the planning stages – planning is critical in the serialization space. Time is of the essence. No manufacturer can afford to commit to a pilot and discover that the system you’ve been working with doesn’t have the proper backup capability in case of a power outage, or any other unforeseen situation.
Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.