Liberty Management Group has opened its in-house eCTD publishing platform, LMG eCTD Pro™, to customers as a self-service product. Companies preparing FDA submissions can now build their own validated eCTD packages online at app.fdahelp.us — starting at $100, one-time.
What LMG eCTD Pro™ Self-Service does
- Upload your submission documents as PDFs — no software to install
- FDA section codes assigned automatically from FDA’s canonical document names, with a built-in naming guide covering DMF, NDA, ANDA, BLA and IND submissions
- Generates the complete eCTD v3.2.2 package: ICH XML backbone, US regional XML, MD5 checksums, and FDA forms placement (356h, 1571, 3938)
- Validates the package against FDA’s DTDs and per-type section mappings before you download
- Pricing by document count: $100 to $500, one-time
Self-service or full service
The same platform continues to power LMG’s full-service offering, where our specialists convert, validate, and submit your dossier through the FDA Electronic Submissions Gateway — with U.S. FDA Agent service included for foreign manufacturers. Straightforward DMFs, amendments, and annual reports are a natural fit for self-service; complex dossiers and lifecycle management remain available as a full service.
Learn more on our eCTD conversion and submission page, or try the tool directly at app.fdahelp.us.