Liberty Management Group Ltd.FDA REGULATORY SERVICES — SINCE 2009LMGeCTD Pro

LMG eCTD Pro™ — Self-Service

Select your submission size based on number of documents

Up to 10 documents
$100 USD
one-time payment
Up to 20 documents
$150 USD
one-time payment
Up to 50 documents
$250 USD
one-time payment
Up to 100 documents
$400 USD
one-time payment
100+ documents
$500 USD
one-time payment

You will be redirected to PayPal to complete payment.
After payment, upload your PDFs and build your submission.
Document count is enforced — select the tier that matches your total number of PDF documents.

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Download a sample eCTD package
A small example build, so you can see exactly what you get before paying.

What LMG eCTD Pro™ does

LMG eCTD Pro™ is self-service FDA eCTD submission software from Liberty Management Group Ltd. You upload your PDFs, the tool assigns the correct FDA section codes, and you download a validated eCTD v3.2.2 package with the regional backbone, the XML index and the folder structure already assembled. It supports DMF, NDA, ANDA, BLA and IND submissions, and handles sequence lifecycle operations — new, replace, append and delete — against the sequences you have already filed.

It is built for the people who own the filing rather than the publishing software: regulatory affairs consultants, small and mid-size pharmaceutical and device companies, API and excipient manufacturers filing Drug Master Files, and anyone who needs a compliant eCTD package without buying a seat in an enterprise publishing suite or outsourcing the build. Section codes are detected from your filenames where possible, flagged for you to confirm where they are not, and every package is checked against the FDA eCTD validation criteria before you download it.

Pricing is a one-time payment per submission, with no subscription and no account to create. Tiers run by document count: $100 for up to 10 documents, $150 for up to 20 documents, $250 for up to 50 documents, $400 for up to 100 documents and $500 for 100+ documents — so $100 to $500 USD depending on the size of your filing. Your uploaded files and details are saved with your access code — return anytime, rebuild in one click, and download. After you download, the exact package stays available for re-download for 24 hours.

Upload your documents as PDFs. FDA accepts PDF versions 1.4 to 1.7, as well as PDF/A-1 and PDF/A-2; files should be text-searchable, and FDA recommends saving them with the “optimize for fast web view” option. The tool checks each upload and tells you if a file falls outside that, without blocking the build.

LMG eCTD Pro™ is a product of Liberty Management Group Ltd. — www.fdahelp.us  ·  Need help? Contact us