Know which version you have
Document identity, managed file revisions, checksums, and version history help distinguish a working document from the exact file it represents.
Regulatory technology · eCTD
Bring clarity to complex submissions.
A more structured path from regulatory documents to eCTD preparation.
Tikana e-CTD is a developing platform for teams seeking a structured way to manage regulatory documents and prepare electronic submissions. Keep document history and configurable regulatory context in view as your process evolves.
In development. Deployment, market-specific rules, and end-to-end submission workflows require further qualification.
A more connected process
From document foundations to submission preparation.
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01
Foundation built
Document control
Document identity, managed file revisions, and history.
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02
In progress
Regulatory setup
Reference catalogs and draft profile management.
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03
Planned
Review and validation
Controlled decisions and qualified validation rules.
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04
Planned
Package and submit
Profile-driven publishing and submission delivery.
Conceptual process illustration, not a product screenshot or an indication that every stage is available.
More control over the details that matter.
The platform is being built around traceable document versions, explicit permissions, and configurable regulatory context—not a one-size-fits-all submission template.
Configure your context
Manage core regulatory reference data and draft profile releases as a foundation for future market- and authority-specific workflows.
Keep access deliberate
Document reads and downloads use explicit permissions. Protected historical references help prevent accidental changes to recorded inputs.
Designed for regulatory teams
A thoughtful path from documents to dossiers.
Tikana e-CTD brings document management and regulatory setup together while building toward controlled dossier preparation, validation, and publication.
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01
Start with trustworthy records
Retain specific revisions and their history instead of relying on an ambiguous “latest file.”
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02
Adapt to the market
Use versioned configuration as a basis for different regulatory contexts, subject to verified official specifications.
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03
Make status meaningful
Separate work in progress from review, approval, and submission; future controlled decisions need qualified evidence.
Product direction
Built in stages. Honest about what comes next.
Current foundations are being extended into a broader eCTD lifecycle. The following workflows are not represented as generally available or qualified.
Future workflow
Dossier assembly
Organize documents into profile-driven CTD sections with exact-version assignments and a clearer view of missing inputs.
Future workflow
Review and validation
Advance through controlled review, technical validation, and regulatory approval with qualified rules and recorded decision evidence.
Future workflow
Publishing and submission
Prepare reproducible eCTD packages, track transmission evidence, and maintain a connected regulatory history.
Initially conceived with Tunisia in view and designed to accommodate additional authorities. No authority endorsement, certified compliance, supported market profile, production readiness, or availability of planned features is implied.
A clearer regulatory workflow starts with a conversation.
Discuss your document process, target markets, and a suitable product walkthrough with the Tikana team. Availability depends on your deployment and qualification needs.
Talk to our team