Regulatory Publishing Services
Submission-Ready.
eCTD, Validated.
A technically perfect submission can still be rejected on formatting grounds. Our regulatory publishing team ensures every submission meets the electronic formatting, structure, and lifecycle requirements of the target health authority.
ValidatedBefore Filing
Overview
eCTD & Electronic Submissions
We compile, format, and validate submissions in eCTD and other required electronic formats, ready for direct filing with regulatory agencies.
Every published submission undergoes technical and compliance validation before filing, reducing the risk of technical rejections or refuse-to-file decisions.
- eCTD compilation to ICH specifications
- Sequence planning for originals, amendments and supplements
- Bookmarking, hyperlinking and technical validation
- Formatting aligned to FDA, EMA and regional requirements
What We Deliver
Publishing & Lifecycle Management
Compilation, formatting and validation, ready for the gateway.
eCTD Compilation
Structuring submissions to ICH eCTD specifications.
Submission Lifecycle Management
Sequence planning for originals, amendments and supplements.
Document Formatting & QC
Bookmarking, hyperlinking, and technical validation.
Publishing Software Support
Compatibility with standard publishing platforms.
Global Submission Publishing
Formatting aligned to FDA, EMA and regional requirements.
5Major Health Authorities
5Global Regions
ISO9001:2015 Certified
10+Years of Expertise
Our Approach
Compile, Validate, File
A publishing pipeline that protects against technical rejection.
01
Structure
Organise documents to the required eCTD module structure.
02
Format
Bookmark, hyperlink and apply granularity.
03
Validate
Run technical validation against agency specifications.
04
Sequence
Plan the lifecycle sequence for the submission.
05
Publish
Deliver a gateway-ready, validated submission.
Why Vigilare
Compliance & Accuracy
No submission held up on formatting grounds.
Validated Every Time
Technical and compliance validation before every filing.
No Refuse-to-File
Formatting that avoids technical rejections.
Lifecycle Fluency
Clean sequences for originals, amendments and supplements.
Platform Flexible
Works with standard, validated publishing platforms.
FAQs
Answered. Clearly.
01
What is eCTD publishing?
eCTD publishing is the process of compiling and formatting a regulatory submission into the electronic Common Technical Document format required by health authorities such as the FDA and EMA.
02
How do I prepare a submission for publishing?
Preparing a submission for publishing involves organising documents according to the required eCTD module structure, validating formatting and hyperlinks, and running technical checks before final submission.
Related Services
Explore the Full Practice
See how our publishing process protects your timeline.
Get eCTD compilation, formatting and validation that keeps your submission out of refuse-to-file territory.