Good clinical practice (GCP) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human...
Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...
According to FDA’s clinical trial regulations (21 CFR 50.20, 312.60 and 812.100), clinical investigators are responsible for protecting the rights, safety, and welfare of subjects during a clinical...
It is quite common that a sponsor company will outsource services to external vendors, whether for additional expertise, remote locations, or simply due to lack of availability of resources within...
Things to consider and how to ease the process IMP Supply Management is a journey where GMP meets GCP and GDP. This journey includes finance, flow of products and documentation. How a company manages...
An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may come in the form of renewed attention towards approaches to vaccine development. The Importance of Vaccines The...
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Introduction: Are you in the development phase for your medicinal product? Have you assessed your manufacturing processes with respect to the requirements for investigating the potential presence of...