Pharmaceutical companies
For regulatory teams managing their own dossiers.
- All of the company's applications and sequences in one place
- A clear view of what was submitted in each sequence
- Reuse of mappings for renewals and variations
eCTD for Bosnia and Herzegovina
Prepare eCTD submissions with less manual work.
Organise documents, manage sequences, check technical rules and prepare a structured XML/ZIP package — in one clear web workspace.
Or write to us at info@ectd.app
Every sequence ends in a structured package
- index.xml
- ba-regional.xml
- index-md5.txt
- ZIP
Why eCTD
Less time on folder structure. More time on the dossier.
The technical side of preparing a sequence — mapping, naming, lifecycle and XML — becomes one guided workflow.
- Area
- Mapping
- By hand
- PDF by PDF, folder by folder
- With eCTD
- Many documents at once, in a single table
- Area
- File names
- By hand
- Checking naming rules by hand
- With eCTD
- Names adjusted to the rules on upload
- Area
- Sequences
- By hand
- Separate spreadsheets to track what went where
- With eCTD
- A sequence lifecycle timeline and lifecycle operations per document
- Area
- Technical checks
- By hand
- Errors found only after submission
- With eCTD
- Selected rules checked before export
- Area
- XML
- By hand
- Editing backbone files by hand
- With eCTD
- index.xml and ba-regional.xml generated automatically
How it works
Four steps to a sequence package.
Step 01
Create an application
Product and procedure details; the profile sets the relevant sections.
Step 02
Map documents
Upload one by one, in bulk or as an existing eCTD folder.
Step 03
Validate
Findings by severity, with a pointer to where to fix them.
Step 04
Export
XML backbone and ZIP package, ready to download.
Document mapping
From a pile of PDFs to a complete eCTD tree.
The document library, eCTD tree and assignment details sit side by side, so you always see what is mapped and what is still missing.
Bulk upload and mapping table
Upload many documents at once and review the mapping before confirming.
Required sections at a glance
The application profile marks what is required, so you work from a list, not from memory.
Copy from the previous sequence
For renewals and variations, carry over existing mapping and working documents.
Validation and export
Fix technical errors before export, not after submission.
Validation runs selected naming, structure, checksum and PDF rules. When no blocking errors remain, export generates the complete sequence package.
Findings by severity and category
Error, Warning and Info with filters — fix what blocks the export first.
Straight to the fix
For most findings, Fix takes you to the related screen or document so you can correct it there.
A package with its report
The ZIP contains the generated XML, MD5 checksums and the util folder, with an HTML validation report alongside the sequence.
SZL-<number>/
├── 0000/
│ ├── index.xml
│ ├── index-md5.txt
│ ├── m1/eu/
│ │ └── ba-regional.xml
│ ├── m2/ … m5/
│ └── util/dtd/, util/style/
├── 0000-validationreport/
│ └── validation-report.html
└── 0000-workingdocuments/Example structure. The SZL number and sequence number come from the application. ZIP export availability depends on the subscription plan.
Included
And everything else a dossier needs.
The capabilities behind mapping, validation and export — available in the application today.
Applications and profile
Product data, procedure type, SZL number and a profile that tailors the eCTD tree.
Sequences and envelope
Sequences 0000, 0001 and onwards, with envelope data and related sequences.
Lifecycle operations
New, replace, delete and append, with prior-document selection.
Working documents
Legal-status evidence and editable product information in a separate package folder.
Existing package import
An existing eCTD ZIP becomes the starting point, with lifecycle and envelope data.
Activity log
Important actions are recorded: recent activity in the sequence workspace, the full audit log for administrators.
Solutions
For in-house teams and for consultants.
Regulatory consultants
For consultants and agencies working for several clients.
- Several companies from a single user account
- Data kept separate per client company
- The same repeatable workflow for every dossier
Compliance
Focused on BiH eCTD requirements — with clear limits.
eCTD is built around the ALMBiH eCTD specification and the EU M1 regional structure it is based on. We want to be precise about what the tool does and what it does not.
eCTD is not an official ALMBiH tool and is not certified or endorsed by any regulatory authority. Passing validation in the tool does not guarantee that a submission will be accepted. Responsibility for the content and correctness of a submission remains with the applicant.
What the tool covers
- The BiH eCTD folder structure: EU M1 regional module and ICH Modules 2–5
- XML backbone per the ICH eCTD v3.2.2 DTD and the BiH regional XML (ba-regional.xml)
- Selected technical rules from the EU M1 validation criteria (v8.2) and BiH naming and structure rules
- PDF technical checks: version, size, encryption and JavaScript, bookmarks and fonts, plus warnings for external links, searchable text, linearisation and attachments
What the tool does not do
- It does not submit to ALMBiH — you download the package and submit it through the official channels.
- It does not assess the scientific or regulatory content of documents.
- It does not cover every possible validation rule; some BiH requirements await confirmation and do not hard-block export.
- It does not support Study Tagging Files (STF) or eCTD v4.0.
Demo
See the application on an example from your own work.
We will walk through the workflow from creating an application to exporting the package and answer questions about your submissions.
What to expect
- A live walkthrough tailored to the submissions you prepare
- A conversation about your current document preparation process
- Answers about the BiH eCTD structure and the tool's limitations
Prefer to write directly?
info@ectd.app