China gets ready to launch eCTD, as companies face a challenging learning curve

by Winnie Yang and Leslie Wan China is gearing up for the implementation of electronic Common Technical Document (eCTD) submissions to accelerate the review and approval of new pharmaceuticals. A year after officially introducing the subject, the life sciences industry in this country is starting to see greater momentum toward implementation. Publication of official specifications […]

4 considerations when choosing a solution for managing global regulatory submissions

by Dawn Waite and Sadia Ahmed There are so many balls in the air when managing global regulatory submissions that it’s all too easy to lose sight of the bigger picture. That picture really should be focusing on the portfolio, building your regulatory intelligence and strengthening your position in the market. But the day-to-day strain […]

Speed and efficiency: The role of automation in an increasingly eCTD world

By Sadia Ahmed and Marcy Miller, DXC Life Sciences The world of the electronic Common Technical Document (eCTD) is closing in on life sciences companies, irrespective of size. The U.S. Food and Drug Administration (FDA) now requires the use of eCTD for all New Drug Applications (NDAs), Abbreviated NDAs, and Biologics License Applications (BLAs), and […]

Someone to watch over you: The benefits of a submission manager

The process of managing a regulatory submission is resource- and time-intensive. Documentation is gathered from years of research, spanning multi-disciplinary functions. All these documents and data are sent to various regulatory authorities, each of which have specific requirements and ongoing demands for more detailed information – further adding to the burdens regulatory departments face. By […]

Industry Change Raises the Need for a Broader Perspective

The life sciences industry is undergoing significant change on all levels – in terms of business model, global regulatory developments and management of processes. All of these changes pose both opportunities and challenges for companies, prompting them to consider what activities they should manage internally, how and where they should partner and how they should […]

Maneuvering a Tricky Landscape: The Growing Interest in Combination Products

There has been a trend in the past few years of life sciences companies crossing into new territory and seeking to submit applications for combination products – in other words products that combine devices and drugs, and/or biological products. That’s hardly surprising since combination products open new market opportunities, but they also add complications for […]

Module 1 Changes Bring Marketing and Regulatory Closer, But Disparities Need to be Managed

Last month some of my colleagues and I attended the DIA’s annual eRegulatory and Intelligence Annual Conference. It was an opportunity to hear about regulatory developments and talk to thought leaders about the changing regulatory environment. On the afternoon of day 1, senior FDA staff members offered an update. In particular, I’d like to focus […]