This capability adds significant value to traditional viewing methods (often limited to eCTD
only) and has been welcomed by the Life Science regulatory community.
includes information on which includes safety, quality and
On a global basis, paper CTDs are still widely accepted in regions unable to manage the advanced technology needed to review an eCTD
Our engagement with TAKE Solutions will enable us to do all regulatory submissions to ICH countries in the specified eCTD
PharmaReady's secure and scalable architecture offers a low-cost alternative to the conventional upfront purchase of an eCTD
/ SPL or DMS platform license.
1) Use the eNDA/eANDA format, (2) use the eCTD
format, or (3) use what is called a "hybrid' 'submission (the older eNDA format with the table of contents organized using the newer CTD headings).
Klaus will join 6 other leading regulatory bodies at the Successful eCTD
Lifecycle Management conference in a key panel discussion focused on the current eCTD
regulatory landscape, working towards bringing about standardisation across Europe and also answering key question posed by the delegation.
Generation of the eCTD
has, by necessity, followed behind the definition of the CTD, since the CTD structure provides the basis for the eCTD