Question 1

What is eCTD validation software?

Accepted Answer

eCTD validation software checks an electronic Common Technical Document submission against the structural, technical, and lifecycle rules published by health authorities before the package is submitted through ESG or a regional gateway. It validates XML backbone integrity, leaf titles, PDF bookmarks, hyperlinks, metadata, checksums, lifecycle operations, and module completeness. The goal is to catch technical defects internally so the submission is not rejected at the gateway or flagged during regulator review. Assyro runs these checks continuously during drafting and publishing instead of only at final assembly, which is when most legacy validators run.

Question 2

What does Assyro's eCTD validator check?

Accepted Answer

Assyro runs 358+ structural and technical checks against the ICH eCTD v4.0.0 specification and the FDA eCTD Technical Conformance Guide. That covers backbone XML integrity, leaf title and file-name conventions, lifecycle operation conflicts (replace, append, new, delete), PDF bookmark and hyperlink integrity, metadata consistency across modules, checksum manifests, granularity rules for Module 2 through Module 5, Module 1 regional completeness, and sequence ordering. Findings are grouped by severity so remediation can start with the items that would block acceptance.

Question 3

Is Assyro's eCTD validator free?

Accepted Answer

Yes. The eCTD Validator tool at /tools/ectd-validator is free with no account required. Upload a sequence and a structural validation report is generated in under 60 seconds, with findings grouped by severity and linked to the clause each check enforces. Files never leave the browser. Teams who need continuous validation across drafting, publishing, and lifecycle operations use the full eCTD Validation capability inside the Assyro workspace.

Question 4

Which eCTD versions does Assyro support?

Accepted Answer

Assyro supports ICH eCTD v4.0.0, including the Regulated Product Submission (RPS) message structure, controlled vocabularies, and lifecycle operations. Earlier v3.2.2 sequences can be validated for structural and technical conformance, which helps teams running mixed portfolios where older INDs still file under v3.2.2 while newer programs move to v4.0.0. Validation rules update as FDA, EMA, and ICH publish revised technical conformance documents.

Question 5

What is the difference between eCTD validation and eCTD publishing?

Accepted Answer

Publishing assembles drafted content into the eCTD file structure: it creates the XML backbone, sets lifecycle operations, organizes leaves into modules, and produces the final package. Validation checks whether that assembled package meets the technical specifications the authority will enforce at the gateway. In most teams, publishing and validation are separate steps run sequentially at the end of the cycle. Assyro runs validation continuously during authoring and publishing so defects are caught during draft, not during final assembly.

Question 6

How much does eCTD validation software cost?

Accepted Answer

The standalone eCTD Validator tool is free. The full eCTD Validation capability inside the Assyro platform is priced by submission volume, program count, and whether lifecycle and publishing capabilities are included. Teams filing 1-3 active programs typically access it as part of a tiered platform plan. Pricing is available at /pricing or through a scoped conversation with the Assyro team. Expect total cost of ownership to be a fraction of legacy publishing tools like eCTDXPress or Lorenz docuBridge because validation and drafting happen in the same workspace.

Question 7

Does validation prevent an FDA Refuse to File?

Accepted Answer

Technical validation prevents the structural and lifecycle defects that trigger an FDA Refuse to File notice at the eCTD technical acceptance stage. It does not prevent content-level RTF decisions, which are based on scientific completeness, clinical data sufficiency, and regulatory adequacy of the submission itself. In practice, most RTF outcomes in eCTD have both technical and content contributors, so teams that validate continuously through the submission cycle remove one category of risk entirely and gain more remediation time for the other.

Question 8

How long does eCTD validation take?

Accepted Answer

Structural validation on a finalized sequence completes in under 60 seconds with the free eCTD Validator tool, regardless of sequence size. Inside the Assyro platform, validation runs continuously as documents are drafted, so by the time the sequence reaches final assembly, structural and lifecycle defects have already been caught and closed. Teams typically reduce final-week validation churn from 30-40 hours of rework to under 5 hours because the remediation is spread across the cycle instead of compressed at the end.

eCTD Validation Software

How eCTD Validation Fits the Submission Workflow

Catch eCTD Blockers at T-30, Not T-2

Reconcile Lifecycle Operations Automatically

Get Fix Instructions, Not Just Error Codes

Keep a Validation Trail Ready for Inspections

Controls and Traceability for eCTD Validation

Keep eCTD Validation Audit-Ready

Scale Across Programs Without Adding Complexity

Questions About eCTD Validation

See eCTD Validation in a Live Submission Workflow.