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.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
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.
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult.
Osstem Implant adopted an integrated business framework that helps it eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
For German pharmaceutical manufacturer Dr. R. Pfleger GmbH, it is very important to monitor and verify pressure conditions as well as humidity and temperature data in its cleanrooms.
Density measurement is a powerful and important method to ensure in-process control (IPC) and quality control of final products in pharmaceutical production facilities.
Clinical packaging, logistics and import/export considerations that should be taken into account when developing a clinical supply strategy in China, Singapore and Japan.
Don't let the complex logistics involved in the handling of clinical supplies in certain regions of the world put your patients at risk or jeopardize both the study budget and timeline.
Successfully sourcing commercial products for comparative studies often proves far more challenging than assumed. A comprehensive plan should include insight from comparator sourcing and clinical supply management, and effective collaboration between these critical functional areas is crucial.
Using workflow based software solutions to guide scientists through various processes in low to high throughput screening campaigns.