China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development by the Chinese government in the last decade, the country’s global industry ranking rose from 9th largest in 2007 to 2nd in 2017. To help expedite the review and approval […]
Successful eCTD Implementation in China: 3 Lessons Learned Read More »
Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical extension of their software tools. The best example is the Microsoft Office package. Although Word is a good program for word processing, text editing and file formatting, a Word-file (.docx)
6 Valuable Tips: Why should you convert to PDF? Read More »
Life Sciences organizations deal with external parties and health authorities on a regular basis. Given the amount of information, tracking all that communication is very challenging and burdensome. “An essential part of any complete RIM platform is the ability to plan and track all day to day regulatory activities that an organization needs to undertake.”
Every industry goes through changes over time and the Life Sciences industry is no exception. But not every change is significant. With so many buzzwords and jargon being thrown around, sometimes it’s hard to wade through the noise and get to the heart of it all.
What are the key disruptors for Life Sciences? Read More »
Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format. In the meantime, the industry is already preparing for major revisions to the way in which information is provided to the health authorities. So, what is next and how will
What’s next after eCTD? Read More »
The electronic submission requirements (CDER/CBER) will apply to the following types of submissions:
Frequently asked questions on the eCTD format (Part 2) Read More »
This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: review notification or in response to a request for additional information What are the
Frequently asked questions on the eCTD submission format (Part 1) Read More »
CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of specifications developed by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) and the Ministry of Health, Labour and Welfare.
A closer look into the eCTD triangle and its modules Read More »
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