Reg-Pub
Our expert operations team is well equipped with exclusive and advanced eCTD tools and plug-ins. We are capable of tracking, executing and managing the regulatory operations of all submission types for our clients.
What we do?
![](https://regweb.ca/wp-content/uploads/2021/05/Compliance.jpg)
Regulatory Publishing
- eCTD support for major markets (US, Europe, Canada, Australia, Switzerland, South Africa, GCC, and Thailand)
- NeeS, country-specific dossier creation
- ASEAN Common Technical Dossier (ACTD) creation
![](https://regweb.ca/wp-content/uploads/2021/05/Medicine.jpg)
Product Lifecycle Management Support
- Variations
- Renewals
- Amendments
- PBRER
- Annual Reports
Regulatory Publishing and Life Cycle Management
![](https://regweb.ca/wp-content/uploads/2021/05/1.jpg)
Document Level Publishing
- Legancy document conversion
- Formating of word document for technical & ease of future revisions
- Bookmarks and hyperlinks creation
- Advanced PDF fixups
![](https://regweb.ca/wp-content/uploads/2021/05/2.jpg)
Submission Level Publishing
- Dossier creation
- Dossier publishing
- Dossier validation
- XML fixups
![](https://regweb.ca/wp-content/uploads/2021/05/3.jpg)
Clinical Study Report Publishing
- Formating, publishing content assembly to ICH requirements
- Publishing compliance review
- Case report form publishing
Our Publishing Tools
eCTD Tool
LORENZ docuBridge
Plug-ins
- LORENZ eValidator
- ISI Toolbox
- eCTD reviewer
- EverMap
- Acrobat Pro