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eCTD Submissions​

Submit your therapeutic product registrations to Singapore HSA

in the required eCTD format.

With LORENZ docuBridge, you can ensure that your submissions are in the right eCTD structure and pre- validated, save time required for registration.​

2,000+
installations
48
countries
19
regulatory authorities

The world already trusts LORENZ.​

Now in Southeast Asia through Factorytalk.​

From Document to Submission. ​
Done Right.​

Multi-format publishing​

Publish multiple output formats from a single sequence: eCTD, NeeS, HTML, PDF, paper and more​

Regulatory document management​

All your documents at your fingertips with the right version and data consistency across departments​

Ad-hoc specification updates​

Receive regulatory submission specification updates automatically without re- installing the software​

Lifecycle management​

Show current and revised versions of sequences and changes made. Organize sequences by regulatory activities​

Team collaboration​

Work as a team on a single regulatory submission sequence and on single documents with no conflicts​

Flexible content reuse​

Replicate content files, hyperlinks, and node properties from a source sequence to a lifecycle sequence in target applications​

Factorytalk Backs Thai FDA in Launching Industry eCTD Submission Service

We led Thailand's first national eCTD implementation with the Thai FDA and have supported both regulators and industry ever since.​ ​

​Factorytalk is confident in providing SG-HSA with a dossier submission solution. ​ ​

Our expertise enables us to deliver reliable, efficient, and compliance focused services that align with SG-HSA requirements and industry best practices.​

Deployment Package​

Our all-inclusive deployment package provides everything required to successfully implement docuBridge TWO. From installation and configuration to user training and technical support, we ensure a smooth, secure, and compliant deployment—helping your team get up and running with confidence.

docuBridge TWO

Install the software on your premise or private cloud

Complete control over your data security and privacy

Unlimited Usage

Unlimited number of dossier publishing

Up to 5 pax system training and admin training

2 eCTD templates upon customer choices

Technical support is available during business hours

Frequently Asked Questions

Find answers to the questions we get asked the most. If you have questions that you can’t find the answer to. Please contact us.

LORENZ docuBridge is among the most established eCTDpublishing platforms globally, with over 2,000 installationsacross 48 countries — including regulatory authorities. 

As an authorized partner, Factorytalk offers Lorenz docuBridgewith turnkey implementation services.

When evaluating an eCTD vendor for Singapore regulatory filings, focus on two key areas:

  1. The solution – Ensure the system is compliant with SG-HSA eCTD requirements, easy to use,stable, and capable of supporting the complete dossier submission process.
  2. The implementation partner – Choose a partner with proven experience implementing eCTDsolutions, not just selling software. The vendor should be able to deliver the project successfullyand provide ongoing support and maintenance after go-live.

Factorytalk has successfully completed over 30 regulatory system implementation projects andcan provide both onsite and remote services for customers in Singapore, helping ensure a smoothimplementation and long-term compliance.

Lorenz is the technology provider for SG-HSA's eCTD solution andis among the first to receive updates to the submissionspecifications. 

This ensures that Lorenz docuBridge stays aligned with the latestSG-HSA requirements, while Factorytalk helps customers deployupdates and maintain compliance.

Yes. Lorenz docuBridge includes a built-in document management modulecalled Regulatory Content Management (RCM). In fact, Lorenz offers a completeRegulatory Information Management (RIM) Suite that supports the entireregulatory submission lifecycle.

In addition, Factorytalk's expertise extends beyond regulatory submissions. As anexperienced provider of electronic Quality Management Systems (eQMS), wehave extensive experience implementing and validating documentmanagement solutions for the life sciences industry.

Want to see what we can do for you?​

Experience Lorenz products for yourself.