eCTD Publishing, format, e Submissions, Regulatory Submissions

eCTD (electronic Common Technical Document) is an electronic format that supports the submission of applications, amendments, supplements and reports to the FDA, EMA and other Health Authorities (HAs) worldwide. It also streamlines the submission process by facilitating the creation and review of electronic data, lifecycle management, and the exchange of information. By integrating the metatags, hyperlinks and bookmarks to the data, it also enables efficient assessment and navigation of Regulatory information that leads to faster reviews by HAs, thus enabling quicker market approvals/authorizations.

With a comprehensive knowledge of global Regulatory publishing trends and submission formats (for example eCTD/Non-eCTD e submissions [NeeS]), Freyr supports dossier submissions across the globe. For efficient, effective and multi-country filings, Freyr offers data compilation, data publishing and dossier dispatches through an in-house Regulatory publishing and submission software, Freyr SUBMIT, that supports global HA submission formats. Adhering to the United States Food and Drug Administration (USFDA), ICH HL7 standards, Freyr is a strategic partner for multiple submissions within brief timelines, which has proven to be very cost-effective for organizations.