Liberty Management Group (LMG) has released LMG eCTD Pro as a self-service product. The platform, which LMG's regulatory specialists have used in-house to prepare and submit FDA eCTD filings, can now be used directly by DMF holders and drug application sponsors at app.fdahelp.us.
What the self-service tool does
LMG eCTD Pro runs entirely in the browser — there is no software to install. Users upload their submission documents as PDFs, and the tool:
- Assigns FDA section codes automatically based on FDA's document naming conventions, with a built-in naming guide for DMF, NDA, ANDA, BLA and IND submissions
- Builds the complete eCTD v3.2.2 package: ICH XML backbone, US regional XML, MD5 checksums, and correct placement of FDA forms such as 356h, 1571 and 3938
- Validates the package against FDA's DTDs and per-type section mappings before download
- Supports original submissions, amendments and annual reports, with sequence lifecycle handling
Pricing is one-time, from $100 to $500 depending on document count.
Self-service or full service
The self-service tier suits straightforward DMFs, amendments and annual reports. For full dossiers and complex lifecycles, LMG's specialists continue to offer complete eCTD conversion, validation and submission through the FDA Electronic Submissions Gateway — with U.S. FDA Agent service included for foreign manufacturers.
Details: fdahelp.us/ectd-submission | Try the tool: app.fdahelp.us
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