e-Submission

With electronic submissions (e-submissions) following the internationally standardized Common Technical Document (eCTD) specification, the transfer of regulatory submissions from applicant to regulators has changed from paper to digital worldwide.

The specification for the eCTD is based on “Extensible Markup Language” (XML) technology and lists the criteria that make an e-submission technically valid.

PhACT is specialized in e-publishing and provides its clients with submission-ready eCTDs.