Free Webinar: Introduction to eCTD

As you may already know, under the draft PDFUA V bill, electronic submissions will be mandated in Q2 2015. Are you prepared? Navigating eCTD regulations and guidelines is easier said than done. Same goes for assembling and reviewing applications. Your application must be technically sound and structured correctly. Most importantly, it has to be ready for review by the agency upon submission. GlobalSubmit Inc., a leading developer of...

Read More
Shift Work Maximizing Regulatory Publishing Efficiency
Mar23

Shift Work Maximizing Regulatory Publishing Efficiency

In a testament to operational efficiency, numerous pharmaceutical companies are borrowing a page from a practice made famous by the manufacturing industry — namely shift work. While the advantage to the manufacturing industry is essentially using facilities and equipment round the clock to produce more goods, the pharmaceutical industry seeks to synchronize regulatory affairs and operation departments around the world. The added twist to this “new” shift work is maximizing the efficiency of highly educated employees with specialized skills located around the world.

Read More

Globalization, Resource Constraints Top List of Regulatory Operations Concerns

On March 10th, I attended the eCTD 2010 conference in Philadelphia. The conference speakers included a number of experienced directors and senior directors of regulatory affairs/reg operations from medium and large Pharma companies. During a panel discussion, an excellent question was posed: What are your biggest challenges – what keeps you up at night? Although we received four different answers from the panelists, they all had a...

Read More