About eCTD Office
eCTD Office is a suite of integrated NeeS / VNeeS / eCTD software products for the creation, validation, viewing, manipulation, archiving and publishing of NeeS / VNeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to regulatory authorities.
Various tools included in the package ensure your work continues flawlesly.
Manage your eSubmissions as simple as 1 - 2 - 3:
1. eCTD Compiler / Publisher
EU eCTD Compiler is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, manipulation and publishing system for EU electronic submissions. The main functionality of the EU eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.
US (FDA) eCTD Compiler. By using the US (eCTD)eCTD Compiler, a part of eCTD Office, several topics including easy STF (study tagging files) generation, lifecycle management and consistency with the eCTD XML DTD and regional validation rules are addressed and solved.
CH Swissmedic eCTD Compiler is a next generation off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing and publishing system for Swissmedic electronic submissions. The main functionality of the Swiss eCTD Compiler is the creation of the eCTD XML backbone (+ envelope data) along with the lifecycle management.
HR eCTD Compiler is an easy to use validation, creation, viewing, manipulation and archiving system for Croatia's national procedures. HR eCTD Compiler creates valid eCTD / NeeS submissions following the guidelines published by Croatia's regulatory authority HALMED.
2. NeeS Compiler / Publisher
EU NeeS Compiler is a next generation off-the-shelf Windows software application for building error-free non-eCTD electronic submissions. NeeS Compiler provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions along with ctd-toc and module TOCs.
AU (TGA) NeeS Compiler ensures the creation of valid Non-eCTD electronic submissions (NeeS) for human medicinal products for Australia's Department of Health and Ageing Therapeutic Goods Administration.
Veterinary VNeeS Compiler is a next generation off-the-shelf Windows software application for building error-free eSubmission for Veterinary Applications. VNeeS Compiler provides quick and intuitive construction of complex, valid electronic submission for a veterinary medicinal product: pharmaceutical, immunological or MRL.
3. Tools
PDF Hyperlink Fixer, a part of eCTD Office, allows to quickly process all PDF documents under a common folder. Use PDF hyperlink fixer to explore links, adjust links, delete links, fix broken links and more.
MRP/DCP Tracking Table Builder is a visual Tracking Table XML builder to be used in the context of Mutual Recognition and Decentralised Procedures, under the Module 1 of the electronic Common Technical Document (eCTD) for the European Union (EU).
FREE eCTD Viewer
eCTD Office eCTD Viewer is a FREE, stand-alone, super-fast, easy to use Windows desktop application for viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD (Electronic Common Technical Document) format.
eCTD Office helps you do the job...
eCTD Office is used by pharma companies and pharmaceutical consultancy companies all over Europe (France, The Netherlands, Belgium, Spain, Czech Republic, Germany, UK, Bulgaria, Ireland, Norway, Cyprus, Malta, Latvia, Lithuania, Sweden, Austria, Finland, Poland, Greece, Estonia ...), United States and Australia.