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?
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
Product Lifecycle Management Support
- Variations
- Renewals
- Amendments
- PBRER
- Annual Reports
Regulatory Publishing and Life Cycle Management
Document Level Publishing
- Legancy document conversion
- Formating of word document for technical & ease of future revisions
- Bookmarks and hyperlinks creation
- Advanced PDF fixups
Submission Level Publishing
- Dossier creation
- Dossier publishing
- Dossier validation
- XML fixups
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
What our clients say
Our clients are the best testament to our acumen and capability.
“We have had the pleasure of working with our partners at RegWeb for several years across many clients and regions. The team are extremely detail orientated and organised when preparing their excellent written documents for regulatory submissions. Additionally, the team are very personable and integrate into projects seamlessly, they are our trusted partners in North America and we continue to build a Rapport year on year!”
Ifty Saiyed
“We from Clarivate Cortellis CMC intelligence team glad to provide this testimony to the work done by RegWeb team on providing the professional services to develop and further maintain the CMC Intelligence database. RegWeb consulting team have always done their best to meet the exact requirements of the CMC project and helped us to achieve the internal milestones to publish the content for Biologics development for identified Regulatory entities across the globe. And now we are pleased to extend their services for Small molecules maintenance as well.”
