The GLOBAL Perspective

The Global Regulatory Blog

Tips for a Successful eCTD Submission

Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to...

5 Scientifically Accurate Horror Movies

Horror movies are not particularly known for their realistic adherence to scientific principles. But we dug up a few that aren’t as far...

The CTA Process Under Regulation (EU) 536/2014: Why Flexible Writing Solutions Are Needed

European Commission, Regulation (EU) No. 536/2014 is challenging the status quo when it comes to clinical trial writing solutions. In...

The Use of Neutral, Unbiased, and Equitable Language in Medical Writing

It is increasingly important in medical writing to recognize diversity in race and ethnicity, sex and gender, sexual orientation,...

How to Strengthen Your Technical Writing

Ready to take your technical writing to the next level? Would you like to learn how to freshen up your writing approach?

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...