Clinical Research Organization, Regulatory, Scientific Writing Services

The change to electronic format has also made matters more complicated. When businesses move to the online standard Electronic Common Technical Document (eCTD) format, they are gradually uncovering some burdens. eCTDs which fail to meet technical validation requirements can result in rejection by health authorities. Health authorities are raising the bar for reliable, compliant eCTDs because of pressure to meet deadlines for the process. The FDA has ordered almost all submission forms to be delivered in eCTD format starting from 2017. As well, other regulatory agencies are shifting to mandate eCTD delivery Need Help: Uk: +44- 7424810299 Email: sales@pepgra.com Whatsapp: +91 9884350006

It is an immense improvement over spending hours in a file room digging through files, taking out volume after volume just being able to pull up a 2-year-old investigational new drug (IND) application and look at it in a current view as well as a historical view in a few clicks. The secret to this significant change is the Popular Electronic Common Technical Document (eCTD) , which represents a major advance in the global march towards electronic regulatory submissions. The eCTD defines how electronic submissions are to be made, reviewed and archived by the International Conference on Harmonization (ICH) back in 2003. Need Help: Uk: +44- 7424810299 Email: sales@pepgra.com Whatsapp: +91 9884350006