The GLOBAL Perspective

The Global Regulatory Blog

Creating Clinical Trial Budgets – Tips & Tricks

Figuring out a proposed budget for clinical sites can be challenging: knowing how to construct and execute the financials are a pivotal...

Designing a Preclinical Program for Your Medical Device

The prospect of designing a preclinical program can be daunting, particularly if there is no precedent for the data needed and relevant...

Choosing the Right Study Site

When choosing the best sites for a study, from the location of the sites to the country, there are many different factors that need to be...

Artificial Intelligence and the Pharmaceutical Industry

Artificial intelligence (AI) is the next big thing coming, and it is already starting to shape our world. Reproduced from Drug Discovery...

Far-UVC and Coronavirus Disinfection

With the arrival of the new coronavirus, SARS-CoV-2, research is growing in the area of rapid, safe limitation of airborne and surface...

GDUFA: Its impact on the Type II Drug Substance Drug Master File (DMF)

The U.S Food and Drug Administration (FDA) has worked with industry to streamline the Abbreviated New Drug Application (ANDA) approval...