Master your DMF easily, quickly and with guaranteed compliance!

DMF in eCTD

Are you looking for an easy-to-use software package to create your DMF submissions in eCTD format? cune-eCTD is built to help you! With very cost-effective pricing and fast set-up, you can get started today. Plus we guarantee your first submission with be 100% eCTD-compliant!

eCTD submission software

Submit Your Drug Master Files (DMFs)

A Drug Master File (also known as DMF) is a submission type that is used to provide confidential detailed information, such as facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs, to the appropriate regulatory authority.

While DMFs were usually submitted with none electronic submissions, recent development of regulatory authorities requires (or will require in future) to submit DMFs in eCTD format (electronic common technical document). Such requirements usually comes with the strict deadlines like most types of DMFs. For full US FDA guidance on electronic submissions please follow the link. Failing to submit your drug master files in eCTD could lead to failure of reaching customers due to suspended providers licence on that specific drug.

Will you be ready to submit your Drug Master Files (DMFs) in the eCTD format by 5th of May 2020? Don´t risk to lose customers. Being ready means making sure your documents are properly prepared (bookmarked, OCR’d, proper orientation), you are able to create your baseline DMF submission as eCTD, and establishing your connection to the FDA (USA) via the Electronic Submissions Gateway (ESG). The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports… no exemptions, no waivers!

cune-eCTD is built for this purpose and manages DMFs quickly, easily and with 100% of compliance!

Checklist: The Road To DMF Readiness

5 crutial steps to your DMFs in eCTD