Does Certara offer AI regulatory writing?

Yes. Certara names CoAuthor as a separate regulatory/medical writing product. Confirm its licence, source controls and handoff to the proposed GlobalSubmit configuration.

Is all GlobalSubmit software browser-only?

Do not assume that. The currently linked fact sheet distinguishes desktop PUBLISH from web REVIEW. Obtain the exact release and technical prerequisites for the applications being purchased.

Do regulator-use claims prove our package will be accepted?

No. A regulator's use of a review tool is not an endorsement of your configured workflow or a guarantee of authority acceptance. Test the relevant profile and retain release evidence.

Can the quoted regional count price or qualify our rollout?

No. Obtain a matrix of authority, format/version, submission type and supported operation. Use the required scenario and actual module terms in procurement.

Comparison/Updated October 2026

Assyro eCTD vs Certara GlobalSubmit

Compare PUBLISH, REVIEW and any CoAuthor writing scope against the document-to-package workflow your team needs.

Assyro eCTD

by Assyro AI

Cloud drafting with source grounding, checks and package production, plus related DMS.

Cited draftingChecks and outputConnected DMSUnlimited users

Certara GlobalSubmit

eCTD publishing, validation and review applications

Named publishing and review functions; writing assistance is separately documented as CoAuthor.

PUBLISH / REVIEWLive validationHyperlink QCSeparate CoAuthor

The verdict

Evaluate Assyro eCTD when source-grounded drafting and approved-profile output are the same project. Evaluate GlobalSubmit when its publishing, hyperlink/QC and reviewer workflow fits your technical operations. Certara separately names CoAuthor for regulatory writing. Include that scope when comparing writing-to-publishing. Also confirm the actual release and deployment: the currently linked fact sheet describes desktop PUBLISH and web REVIEW, while older versioned help describes a desktop review configuration.

Individually written by Assyro AI, a compared vendor. Current product pages, currently linked two-page fact sheet and explicitly versioned 25.3.1 help checked October 13, 2026. Different revision scopes are identified; vendor speed claims are not adopted as our observed results.

Writing, publishing and reviewing are separate acceptance jobs

Compare the applications needed to complete all three.

Named product scope
Job	Assyro	Certara
Source-grounded writing	eCTD drafting	Related CoAuthor
Controlled records	Related DMS	Confirm source/approval system
Publish and check	eCTD workflow	GlobalSubmit configuration
Reviewer access	Evaluate required access	Verify REVIEW release/deployment

Source-grounded writing
Assyro
eCTD drafting
Certara
Related CoAuthor
Controlled records
Assyro
Related DMS
Certara
Confirm source/approval system
Publish and check
Assyro
eCTD workflow
Certara
GlobalSubmit configuration
Reviewer access
Assyro
Evaluate required access
Certara
Verify REVIEW release/deployment

[2][4][5][6]

Use a release-specific proposal

A current platform summary and historical help can both be authentic while describing different configurations. Retain the proposal's version, deployment and application responsibilities as the controlling evaluation evidence.

Assyro's approved output scope is v3.2.2 for FDA, Health Canada and EMA centralised, plus v4.0 for FDA and EMA initial MAA. Confirm the exact regional implementation and operation for either vendor.

[2][3][5]

Feature by feature

Published capabilities, related applications and evidence still to request.

Regulatory drafting
Assyro eCTD
Source-grounded eCTD drafting[5]
GlobalSubmit
Related CoAuthor product; confirm inclusion and handoff[4]
Publishing and QC
Assyro eCTD
Approved eCTD profile workflow[5]
GlobalSubmit
GlobalSubmit publishing, hyperlink and bookmark tools[1]
Technical validation
Assyro eCTD
Checks in the submission workflow[5]
GlobalSubmit
Live validation; obtain release/profile evidence[1]
Deployment and review
Assyro eCTD
Cloud workspace[5]
GlobalSubmit
Current fact sheet: desktop PUBLISH, web REVIEW[2][3]
Controlled source
Assyro eCTD
Related Assyro DMS[6]
GlobalSubmit
Confirm approval and source-record boundary[1]
Pricing
Assyro eCTD
Custom pricing, unlimited users[7]
GlobalSubmit
Request matched application and service terms[1][4]

Assyro eCTD and Certara GlobalSubmit: feature comparison
Capability	Assyro eCTD	GlobalSubmit
Regulatory drafting	Source-grounded eCTD drafting[5]	Related CoAuthor product; confirm inclusion and handoff[4]
Publishing and QC	Approved eCTD profile workflow[5]	GlobalSubmit publishing, hyperlink and bookmark tools[1]
Technical validation	Checks in the submission workflow[5]	Live validation; obtain release/profile evidence[1]
Deployment and review	Cloud workspace[5]	Current fact sheet: desktop PUBLISH, web REVIEW[2][3]
Controlled source	Related Assyro DMS[6]	Confirm approval and source-record boundary[1]
Pricing	Custom pricing, unlimited users[7]	Request matched application and service terms[1][4]

Product details and recommendations reflect publicly available information and our own assessment as of October 2026, provided for comparison. Certara GlobalSubmit is a product of Certara; trademarks belong to their respective owners.

Which one should you choose?

Choose Assyro eCTD if

Source traceability and drafting are part of the immediate bottleneck.
The required regional output is within approved scope and passes a lifecycle pilot.
You want to evaluate source control alongside writing and output.

Choose GlobalSubmit if

The GlobalSubmit QC and reviewer tasks fit your established publishing operation.
A demonstrated regional profile outside approved Assyro scope is required.
You want to evaluate CoAuthor's Word-based writing alongside the publishing applications.

The detailed comparison

What is the installed and hosted application boundary?

Assyro eCTD

Test writer, publisher and external-reviewer access in the proposed cloud workflow. Include exports and user revocation in acceptance.

GlobalSubmit

Record the actual PUBLISH/REVIEW/validation release and prerequisites. The 25.3.1 help page and current fact sheet describe different review arrangements; ask which applies to your proposal.

[2][3][5]

Can late document changes pass through QC safely?

Assyro eCTD

Correct a source statement and verify citations, approved revision and output before release. Check the earlier output after the correction.

GlobalSubmit

Change a document after assembly, then inspect its links, bookmarks, validation findings and reviewer view. If CoAuthor is included, demonstrate the document handoff rather than assuming an automatic connection.

[1][4][5]

Include the writer and reviewer applications in the cost model

Request software/access, environments, regional profiles, writing tools, technical prerequisites, services, support and update terms. Match those lines to the same accepted job in the Assyro quote.

Add source preparation, desktop/hosted administration, training, validation/acceptance, history migration, release assessment and exit work. Do not convert a vendor efficiency statistic into a saving estimate for your team; measure the sample tasks first.

[1][4][7]

A QC pilot that can expose incorrect results

Use deliberate defects rather than judging a preselected clean package.

Source contradiction

Include conflicting source values. Require the writer to find and resolve the conflict before approval.

Late revision

Replace a document with changed links and bookmarks, then reconcile the output and reviewer view.

History

Import a prior application and create the required next operation without corrupting references.

Independent retrieval

Have a different reviewer retrieve the package, findings and source inventory; revoke access and confirm the permission boundary.

Where GlobalSubmit is stronger

No tool wins on everything. Here is where GlobalSubmit is the better choice today.

Documented publishing automation and hyperlink/bookmark QC functions.
A separately documented web review offering in the current fact sheet.
A related regulatory-writing product for buyers who want to keep work in Microsoft Word.

Adopting Assyro eCTD

Treat a publisher change separately from a writing-tool change. No live cross-vendor connector is established here. Retain the accepted GlobalSubmit workflow until a representative imported history and next output pass your acceptance criteria.

1Inventory application histories, source records, findings and acknowledgements.
2Map identifiers, references and any review artifacts that must be retained.
3Import a sample and reconcile current/historical views.
4Produce a next sequence and inspect it with a separate reviewer workflow.
5Approve record ownership, exceptions, cutover and rollback.

Sources and evidence

Product documents establish published scope. Evaluation scenarios and recommendations are Assyro's analysis. Confirm availability, configuration and contract scope with each vendor.

Certara GlobalSubmit
Current publishing, live validation and hyperlink/QC scope; checked October 13, 2026; no revision displayed
Currently linked GlobalSubmit fact sheet
Two-page document: PUBLISH desktop on page 1; REVIEW web on page 2; copyright 2026; current linked PDF checked October 13, 2026, filename not treated as release verification
GlobalSubmit 25.3.1 help
Explicit help version 25.3.1, application relationship and desktop Review scope; checked October 13, 2026; not asserted as current release
Certara CoAuthor
Separate Word-integrated regulatory writing offering and source-grounding scope; checked October 13, 2026
Assyro eCTD product scope
Published product definition and capability scope; checked October 13, 2026; related applications require their own quoted scope
Assyro DMS product scope
Published product definition and capability scope; checked October 13, 2026; related applications require their own quoted scope
Assyro pricing
Published custom pricing and unlimited users on every plan; checked October 13, 2026; no competitor price advantage inferred