Reduce the Risk & Anxiety Around Drug Master File Submissions
The U.S. FDA mandate of Electronic Common Technical Document (eCTD) compliant Drug Master File (DMF) submissions has added more risk and anxiety to the regulatory filing process. The FDA was cautious with the implementation of the mandate, acknowledging concern for filers and fear of high rejections.
The implementation date for the eCTD requirement for Type III DMFs has been extended to May 5, 2020. New DMFs other than Type III DMFs must be submitted using eCTD as of May, 2018.
Now is the time to be planning for the FDA's 2020 DMF mandate. Synchrogenix is uniquely positioned to support companies with DMF submissions through an industry-leading Regulatory submissions group and innovative cloud-hosted software solutions which have been supporting FDA and industry for over 15 years.
DMF eCTD Service and Software Options
Regulatory Services for Compliant DMF eCTD Submissions
- Document formatting services
- Document-level publishing including the creation/verification of hyperlinks and bookmarks
- Submission-level publishing services
- eCTD Implementation
eCTD Software for DMF Publishing and Review
Synchrogenix's GlobalSubmit PUBLISH simplifies eCTD publishing and ensures 100% regulatory compliant PDF documents through auto processing.