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 […]