About eCTD Office
eCTD Office is a suite of integrated eCTD / NeeS / VNeeS software products for the creation, manipulation, validation, publishing and viewing of regulatory documentation for electronic submission by pharmaceutical companies to regulatory authorities.
Various tools included in the package ensure your work continues flawlessly.
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.
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.
US (FDA) eCTD Compiler. By using the US (FDA) 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.
CA (HCSC) eCTD Compiler. By using the CA (HCSC) eCTD Compiler, a part of eCTD Office, several topics including easy electronic submission generation, lifecycle management and consistency with the eCTD XML DTD and regional CA validation rules are addressed and solved.
GCC (Gulf Cooperation Council) eCTD Compiler. By using the GC (SFDA) eCTD Compiler, a part of eCTD Office, several topics including easy electronic submission generation, lifecycle management and consistency with the eCTD XML DTD and GC regional validation rules are addressed and solved.
Looking for ZA (South Africa) eCTD?
eCTD Office supports ZA eCTD submissions, fully implementing M1 (+M3) Medicines Control Council specific requirements! Contact us for more info.
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.
GCC NeeS Compiler ensures the creation of valid Non-eCTD electronic submissions (NeeS) for human medicinal products for GCC (Gulf Cooperation Council) countries.
AU (TGA) / NZ (Medsafe) 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 and New Zaeland's Medicines and Medical Devices Safety Authority.
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
pCTD Compiler, a part of eCTD Office, allows for quick conversion of an electronic submission, be it a NeeS or eCTD for human products or VNeeS for veterinary products, to paper based version supporting generation of volumes, tab sheets and an overall table of content based on the dossier hierarchical structure.
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 and New Zealand.