DDReg offers Comprehensive eCTD Publishing and Submission Services.
While some regions accept paper dossier submissions, the eCTD format has been declared mandatory by many regulatory authorities worldwide. Thus, the need to convert paper INDs, NDAs and DMFs to the eCTD format is imperative. Marketing authorization applications must be technically compliant with respect to submitted documents. To ensure appropriate assessment of the regulatory procedures, the baseline sequence must be submitted. This should include the compiled dossier in the eCTD or as a NeeS. Technical assessment of the eCTD against ICH specifications is a requirement to ensure validation before it can be submitted.
DDReg ensures appropriate conversion of dossiers, while adhering to guidelines and specifications. DDReg uses fully validated eCTD tools that are 21CFR part 11 compliant.
DDReg’s publishing services include:
Legacy dossier conversion to CTD as NeeS or as eCTD
Publishing initial applications, query responses, variations, aggregate reports using eCTD tool
eCTD submission through agency web portal or gateway
Maintaining product specific filing sequence for initial submission & response to queries