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FDA eCTD Conversion, Submission & U.S. Agent

FDA requires eCTD (electronic Common Technical Document) format for DMF, NDA, ANDA, BLA, and commercial IND submissions. LMG converts your existing drug dossier into FDA-compliant eCTD format, validates it against FDA’s technical specifications, and submits it through the FDA Electronic Submissions Gateway — powered by our proprietary LMG eCTD Pro™ platform. Prefer to do it yourself? Build your own eCTD package online from $100.

eCTD Conversion & Publishing LMG eCTD Proâ„¢ Technology U.S. FDA Agent Included Since 2009

About FDA eCTD Conversion & Submission

The electronic Common Technical Document (eCTD) is the internationally harmonized format (ICH M8) required by the FDA for electronic drug dossier submissions. Since May 2018, FDA has mandated eCTD for all Drug Master File (DMF) submissions. It is also required for NDAs, ANDAs, BLAs, and commercial INDs submitted electronically (non‑commercial investigator INDs are exempt from the eCTD mandate).

eCTD requires a precise XML backbone, document organization per ICH M4, validated publishing software, and manual upload to the FDA Electronic Submissions Gateway by LMG via our registered account. LMG’s LMG eCTD Proâ„¢ handles the entire technical conversion and submission process — so you don’t need to invest in specialized software or technical staff.

Our eCTD services cover:

  • eCTD Conversion of existing drug dossier documents
  • eCTD Publishing — XML backbone construction (ICH M4)
  • Technical validation — XML backbone (DTD) validation, MD5 checksum verification, FDA forms & section-code checks
  • FDA ESG submission for DMF, NDA, ANDA, IND, BLA
  • eCTD Amendments, Supplements & Annual Reports
  • Lifecycle management — sequences, superseded documents
  • U.S. FDA Agent service for foreign manufacturers
  • Submission tracking, confirmation & FDA correspondence

Important: LMG's eCTD service covers conversion, publishing, and submission of your existing dossier content. We do not prepare the underlying scientific or technical content. Contact us if you need content preparation — we will connect you with the right specialists.

Why Clients Choose LMG for eCTD
Proprietary LMG eCTD Proâ„¢ Platform
Built in-house by LMG — no outsourced technical work. Always aligned with the latest FDA eCTD specifications.
Pre-Submission Technical Validation
LMG eCTD Proâ„¢ validates your eCTD package against FDA’s current technical specifications before filing — catching structural and formatting errors that cause technical rejections.
U.S. FDA Agent Included
Foreign manufacturers get eCTD conversion, ESG upload, and U.S. Agent service in one engagement.
Technical Rejections Handled Free
If FDA returns a technical reject, LMG corrects and resubmits via eCTD Proâ„¢ at no additional charge.
Proprietary LMG Technology

Introducing LMG eCTD Proâ„¢

LMG eCTD Pro™ is Liberty Management Group's in-house eCTD publishing platform built for FDA electronic submissions — originally built for our specialists and now also available to customers as a self-service product. It converts your dossier documents into a fully validated eCTD package — with the correct XML backbone, ICH M4 document organization, and metadata — then uploads to the FDA ESG via LMG's registered account. No third-party publishing tools. No outsourced technical work. Built and maintained entirely by LMG — and offered two ways: use it yourself at app.fdahelp.us from $100, or have our specialists operate it for you as a full service.

Automated XML backbone construction per FDA eCTD guidance
Pre-submission validation against FDA's current eCTD technical specifications
ICH M4 document granularity & metadata auto-assignment
Lifecycle management — amendments, supplements, annual reports
LMG uploads your validated eCTD package to FDA ESG — acknowledgment and confirmation delivered to you
Request eCTD Conversion
LMG eCTD Proâ„¢ Capabilities
eCTD Builder — Constructs FDA-compliant XML backbone with proper section hierarchy
Validator Engine — Validates eCTD structure against FDA technical specifications before filing
Document Organizer — Bookmarks and organizes PDFs per ICH M4 granularity rules
Lifecycle Tracker — Manages sequences, amendments, and superseded documents
ESG Upload — LMG logs into FDA ESG via our registered account and manually uploads your validated eCTD package — acknowledgment delivered to you

How eCTD Conversion & Submission Works at LMG

Our 4-step process — powered by LMG eCTD Pro™ — takes your dossier from raw documents to a validated, accepted FDA submission.

Step 1 — Document Submission & Scope Review
You provide your existing dossier documents (PDFs, Word files, or existing non-eCTD electronic submissions) along with a table of contents. Our team reviews the scope to confirm submission type (DMF, NDA, ANDA, IND), sequence number, and ICH M4 section mapping. We identify any missing documents or formatting issues before conversion begins.
Step 2 — eCTD Conversion & Publishing via LMG eCTD Pro™
Our specialists load your documents into LMG eCTD Pro™, which constructs the eCTD XML backbone per FDA guidance (M2 EWG standard), assigns correct ICH M4 section codes and document granularity, applies required PDF bookmarks and metadata, and assembles the complete eCTD package — ready for validation.
Step 3 — Technical Validation & Client Review
LMG eCTD Proâ„¢ runs pre-submission validation checks against FDA's current eCTD technical specifications, catching errors before they reach FDA. You receive a validation report and a structured content summary for review and sign-off. Any issues are resolved before submission.
Step 4 — FDA ESG Submission, Confirmation & U.S. Agent Support
LMG submits the validated eCTD package to the FDA Electronic Submissions Gateway (ESG) using your registered FDA account (or through LMG as your U.S. Agent). You receive the submission confirmation, acknowledgment number, and we handle all subsequent FDA technical correspondence and resubmissions if required — at no additional charge.

eCTD Submission Types We Handle

LMG eCTD Proâ„¢ supports all major FDA submission types that require eCTD format.

Drug Master File (DMF)
eCTD conversion and submission for Type II (API), Type III (Packaging), Type IV (Excipient), and Type V DMFs. Mandatory eCTD format since May 2018. Amendments and annual reports included.
NDA & ANDA Submissions
eCTD publishing for New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA), including original submissions, amendments, supplements, and annual reports.
IND Applications
eCTD conversion for Investigational New Drug Applications (IND) — original IND, IND amendments, and annual reports — formatted per FDA eCTD guidance for INDs.
BLA Submissions
eCTD publishing and submission for Biologics License Applications (BLA) and related amendments, supplements, and post-approval reports.
Amendments & Annual Reports
eCTD lifecycle management — converting and submitting amendments, major and minor supplements, and annual reports as new sequences in an existing eCTD submission.
U.S. FDA Agent Service
LMG serves as your designated U.S. FDA Agent — the legally required point of contact between FDA and foreign drug manufacturers. Included with eCTD submission service.
NEW — SELF-SERVICE OPTION

eCTD Submission Cost — LMG eCTD Pro™ Self-Service vs Full Service

Not every submission needs a full-service engagement. With the LMG eCTD Pro™ self-service you upload your PDFs, section codes are assigned automatically from FDA’s naming conventions, and you download a validated, gateway-ready eCTD package in minutes — from $100 one-time.

LMG eCTD Proâ„¢ Self-Service LMG eCTD Proâ„¢ Full Service
Who does the workYou upload PDFs; the tool builds and validates the packageLMG specialists convert, validate, and submit for you
Section codesAuto-detected from FDA canonical filenames, with a built-in naming guideMapped by LMG regulatory specialists
ValidationXML backbone (DTD) validation, MD5 checksums, FDA section checksSame engine, plus specialist review and sign-off
FDA gateway submissionYou submit via your ESG account, or add LMG U.S. Agent serviceLMG submits via our registered ESG account; confirmation delivered
Price$100–$500 one-time (by document count)Quoted per dossier — request a quote
Best forStraightforward DMFs, amendments and annual reportsFull dossiers, complex lifecycles, foreign manufacturers needing a U.S. Agent

eCTD Conversion & Submission — Frequently Asked Questions

Common questions about FDA eCTD format requirements and LMG eCTD Proâ„¢ submission services.
eCTD (electronic Common Technical Document) is the internationally harmonized format (ICH M8) for submitting drug regulatory dossiers electronically. FDA requires it because it enables structured, searchable, and lifecycle-managed submissions that can be processed efficiently. Since May 2018, FDA has mandated eCTD for all Drug Master Files. NDAs, ANDAs, INDs, and BLAs submitted electronically must also use eCTD format. Paper and non-eCTD electronic submissions are no longer accepted for new DMF filings.
FDA requires eCTD for: Drug Master Files (DMF) — all types, mandatory since May 5, 2018; New Drug Applications (NDA) and amendments; Abbreviated New Drug Applications (ANDA) and amendments; Investigational New Drug Applications (IND); Biologics License Applications (BLA); and all related supplements, amendments, and annual reports filed as part of these application types.
LMG eCTD Proâ„¢ is Liberty Management Group’s proprietary platform for eCTD conversion, publishing, and FDA submission. It automates XML backbone construction per FDA guidance, runs pre-submission technical validation checks before submission, organizes documents per ICH M4 granularity rules, manages submission lifecycle, and uploads to the FDA ESG via LMG’s registered account. Because it is built and maintained entirely by LMG, it is always aligned with the latest FDA eCTD technical specifications — reducing the risk of technical rejections that delay drug approvals.
LMG’s eCTD service covers conversion, publishing, and submission only. We take your existing dossier documents and convert them into FDA-compliant eCTD format using LMG eCTD Proâ„¢. We do not prepare the underlying scientific or technical content of the dossier — such as CMC data, analytical methods, stability studies, or clinical study reports. If you need content preparation, please contact us and we will connect you with appropriate regulatory writing specialists.
Yes. Foreign drug manufacturers must designate a U.S. FDA Agent before submitting drug applications, DMFs, or any regulatory correspondence to FDA. The U.S. Agent is the legally required point of contact for all FDA communications. LMG provides U.S. FDA Agent service in conjunction with eCTD submission — making us a single-source solution for foreign manufacturers filing with FDA.
A Letter of Authorization (LOA) is issued by the DMF holder to grant a specific drug applicant the right to reference the DMF in their NDA or ANDA. The LOA must be submitted to FDA both by the DMF holder (incorporated into the DMF) and by the drug applicant (as part of their application). LMG prepares LOA documents and ensures proper eCTD formatting for LOA submissions.
LMG monitors all eCTD submissions through the FDA ESG. If FDA returns a technical rejection (TR), our team analyzes the specific TR reason codes, corrects the eCTD package in LMG eCTD Pro™, and resubmits — at no additional charge. Technical rejections are typically resolved and resubmitted within 1 business day of receiving the FDA response.

Self-service: $100–$500 one-time using the LMG eCTD Pro™ self-service portal, priced by document count — you upload PDFs and download a validated package. Full-service conversion, validation, and FDA ESG submission by LMG is quoted per dossier — contact us for a quote.

Yes. The LMG eCTD Pro™ self-service portal lets you upload your PDFs, auto-assigns FDA section codes from the built-in naming guide, validates the XML backbone and checksums, and gives you a gateway-ready eCTD package — from $100. If you prefer, LMG’s full service handles conversion, validation, and ESG submission for you, with U.S. Agent service for foreign manufacturers.

Self-service packages are built and validated in minutes through the online tool. Full-service conversion timelines depend on dossier size and completeness — the schedule is confirmed during the scope review in Step 1, and most conversions complete within 5 business days.

eCTD v4.0 is the next-generation ICH submission standard. FDA has accepted v4.0 submissions on a voluntary basis since 2023, and mandatory use is expected around 2028. The currently required standard remains eCTD v3.2.2 — LMG tracks the transition so your submissions stay compliant as FDA’s timeline firms up.

Ready to Submit Your eCTD Filing?

LMG eCTD Pro™ converts and submits your drug dossier to FDA with technical precision — validated, compliant, and accepted. U.S. FDA Agent service included for foreign manufacturers.