Question 1

What is Assyro Validation?

Accepted Answer

Assyro Validation is eCTD validation software that checks submissions against each health authority's technical criteria before you file, part of the Assyro AI compliance platform. It checks eCTD v3.2.2 sequences against the FDA eCTD validation criteria (version 4.6), Health Canada's eCTD validation rules (version 5.3) and the EU eCTD validation criteria (version 8.2, centralised procedure). It checks eCTD v4.0 sequences against the FDA criteria (version 1.6) and the EU criteria (version 1.1, initial marketing authorisation application sequence only). Teams can buy it on its own or get it as part of Assyro eCTD.

Question 2

Can I use Assyro Validation with my existing publishing tool?

Accepted Answer

Yes. Keep publishing in docuBridge, Veeva Vault or any other tool. Upload the zipped sequence to the validation workspace in Assyro and run validation against the criteria of the authority it is going to. The sequence does not need to be rebuilt in Assyro. If you later want to manage the application's lifecycle in Assyro, the same package can be imported as a submission.

Question 3

Is Assyro Validation included in Assyro eCTD?

Accepted Answer

Yes. Assyro eCTD includes Assyro Validation, so sequences authored and published in Assyro eCTD are validated in the same workspace where they are built. Teams that keep their current publishing tool and only need validation can buy Assyro Validation on its own.

Question 4

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 5

What does Assyro Validation check?

Accepted Answer

Assyro checks each sequence against the published validation criteria of the authority it is going to: FDA, Health Canada, or EMA. 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 6

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 the browser, 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 7

Which eCTD versions does Assyro support?

Accepted Answer

Assyro builds and validates eCTD v3.2.2 sequences for FDA, Health Canada, and EMA, and eCTD v4.0 sequences for FDA and for the initial sequence of an EMA centralised marketing authorisation application. Each sequence is checked against its authority's published criteria: the FDA eCTD validation criteria (version 4.6 for v3.2.2, version 1.6 for v4.0), Health Canada's eCTD validation rules (version 5.3), and the EU eCTD validation criteria (version 8.2 for v3.2.2 in the centralised procedure, version 1.1 for v4.0). Health Canada submissions use v3.2.2 only.

Question 8

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 9

How much does eCTD validation software cost?

Accepted Answer

The free eCTD Validator at /tools/ectd-validator lets teams check a sequence at no cost, with no account required. The full eCTD Validation capability inside Assyro eCTD uses custom pricing scoped to your workflows and rollout, with unlimited users on every plan, so there is no per-seat cost. See /pricing or book a call to get a tailored proposal.

Question 10

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 11

When does eCTD validation run?

Accepted Answer

With Assyro Validation on its own, you upload a finished sequence and run validation on it before filing, as often as you need. Inside Assyro eCTD, validation runs as the sequence is built, so structural and lifecycle defects surface while documents are still being drafted. Final-week validation churn drops because the remediation is spread across the cycle instead of compressed at the end.

eCTD Validation Software That Catches Defects Before Submission Lock

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

Guides for your next decision

Questions About eCTD Validation

See eCTD Validation in a Live Submission Workflow.