Centralised, National, DCP, MRP
U.S. Food and Drug Administration
Swiss Agency for Therapeutic Products
Health Canada Santé Canada
Saudi Food & Drug Authority
Jordan Food and Drug Administration
Australian Therapeutic Goods Administration
Thai Food and Drug Administration
South African Health Products Regulatory Authority
China NMPA CDA
Singapore HSA
Ukraine SEC-MOH
World Health Organization PQT
Therapeutic Goods Administration
Agencija za lijekove i medicinska sredstva Bosne i Hercegovine
Non-eCTD EU Electronic Submissions
Agencija za lekove i medicinska sredstva Srbije
Swissmedic VNeeS: pharmaceutical, biological, immunological
EU VNeeS: pharmaceutical, biological, immunological or MRL
GCC VNeeS: pharmaceutical, biological, immunological or MRL
Prior to filing your eCTD (Electronic Common Technical Document) submissions to regulatory agencies you should make certain your sequences are technically valid.
(Re)viewing and understanding the granularity of an eCTD lifecycle for *free*. eCTD Viewer for EU, US, CA, CH, AU, TH, GCC, JO, ZA and other ICH eCTD regions.
Create, view, edit, annotate (create links), OCR and digitally sign PDF files. Convert, merge documents, extract pages, optimize, generate bookmarks, add headings, ...
PDF documents and hyperlinks: explore, adjust, delete, fix broken, optimize, ...
Compare two eCTD sequences visually instantly. Missing files, orphan/empty folders, differences in MD5, ...
Quick conversion of an electronic submission to paper.
What do you want to publish today?
Freemium support. Free updates. No hidden costs. 15+ years!
AU/NZ NeeS Compiler, a part of eCTD Office, is an authenticated NeeS preparation, creation, manipulation, validation and publishing system for TGA/Medsafe electronic submissions for human medicinal products.
eCTD Office produces valid TGA/Medsafe NeeS electronic submissions .
Provides tools for quick and intuitive construction of complex, valid non-eCTD electronic submissions.
The main functionality of the AU/NZ NeeS Compiler is the creation of valid TGA/Medsafe electronic Non-eCTD dossier submissions along with hyperlinked CTD-TOC and Module TOC generation.
Built in validation supporting regional rules ensures no invalid submissions can be generated.
Conforms to TGA's Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in Australia and New Zealand.
Regularly updated following the changes in the TGA / ICH eCTD specification.
Save time and money with your next submission!
Complex XML and other IT related features hidden from you!
Embedded Validation Criteria.
Speed up your work, create pre-populated compilations.
Let eCTD Office take care of converting your Word documents to PDF.
Easily combine several PDF documents for a single published document.
Ensuring your PDF hyperlinks are valid and functional.
Conversion to PDF version 1.4, optimization for fast web view, ...
Easy-to-use intuitive user interface.
Open (applicant's) / Closed (restricted) part export for Active Substance Master Files (ASMF) submissions.
Do not worry about high level programming aspects of an electronic submission.
Automatic optimization: removal of orphaned files and empty sections.
A validation system that helps you resolve naming and other errors during compilation time.
More than 250 ICH and specific regional validation rules.
Merging of existing eCTD submissions into a new / renewal submission with leaf operation re-assigning.
Customizable validation rules to allow the preparation of eCTD submission specific to your country.
No extra server components are needed for the system.
Auto creation and packaging of eCTD compliant electronic submissions.
Automatic attribute and envelope / regional metadata elements generation from previous sequences.
Commonly used tasks such as submission validation, document merging, adding PDF cross-references.
Easy country specific envelope creation.
Connect to your prefered DMS.
Submit faster in teams - merge compilation from your team members.
The Australian Regulatory Guidelines for Biologicals published by the TGA in June 2011 stipulate a specific dossier structure for registration of human cell and tissue-based therapeutic goods (collectively defined as 'biologicals'). Use eCTD Office Templated Compiler to generate the precise dossier structure quickly and easily, save the template and use for all subsequent submissions. A fully bookmarked, hyperlinked Table of Contents is generated when the dossier is published, for ease of navigation and evaluation at the TGA.
Customised templates for compilation and publishing of NMAs for evaluation under either the non-abbreviated process or the extended abbreviated process can be generated quickly and easily. Convert TGA, FDA, Health Canada, EMA and MHRA dossiers to the format required by Medsafe with minimal additional manipulation. Save customised templates for future use. All dossiers published using eCTD Office are fully hyperlinked and bookmarked to the Table of Contents that is generated, facilitating navigation and evaluation at Medsafe.
Various productivity tools included in Mono eCTD Office ensure your work continues flawlessly. Need PDF editing (OCR, bookmarks, TOC generation, security, fast web view, ...)? Included. Need to compare PDF documents? Included. Need to compare two sequences? Included. Need to check your entire set of PDF documents for broken hyperlinks? Included.
PDF Editor / Pharma Toolbox, PDF Hyperlink Optimizer, Submission Comparer.
Prior to filing your electronic submissions to regulatory agencies you should make certain your sequences are technically valid. Streamline you review process, reduce response times to Agency requests, and ensure faster approvals for your products.
Mono eCTD Validator and Mono eCTD Viewer are included in Mono eCTD Office!
