EU NeeS Compiler

EU NeeS Compiler - European Non-eCTD

EU NeeS Compiler, a part of eCTD Office, is a NeeS creation, manipulation, validation and publishing system for EU electronic submissions for human medicinal products.

eCTD Office produces valid European NeeS electronic submissions: national, centralised, MRP (mutual-recognition) or DCP (decentralised).

Fully compliant with EU Module 1 Specification.

The main functionality of the EU NeeS Compiler is the creation of valid European 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 TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU.

Regularly updated following the changes in the EMEA / ICH eCTD specification.

Mono eCTD Office's eSubmission Compiler Main Features

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    Save time and money with your next submission!

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    Understand eCTD

    Complex XML and other IT related features hidden from you!

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    Create valid eSubmissions

    Embedded Validation Criteria.

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    Create eCTD templates

    Speed up your work, create pre-populated compilations.

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    Convert MS Word to PDF at publishing

    Let eCTD Office take care of converting your Word documents to PDF.

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    Split / merge PDF documents

    Easily combine several PDF documents for a single published document.

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    Create / auto-correct PDF hyperlinks

    Ensuring your PDF hyperlinks are valid and functional.

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    Powerful PDF processing features

    Conversion to PDF version 1.4, optimization for fast web view, ...

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    Intuitive Interface

    Easy-to-use intuitive user interface.

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    ASMF submissions

    Open (applicant's) / Closed (restricted) part export for Active Substance Master Files (ASMF) submissions.

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    Automatic MD5 checksum generation

    Do not worry about high level programming aspects of an electronic submission.

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    Automated optimization

    Automatic optimization: removal of orphaned files and empty sections.

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    In-place validation

    A validation system that helps you resolve naming and other errors during compilation time.

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    More than 250 ICH and specific regional validation rules.

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    Document merging

    Merging of existing eCTD submissions into a new / renewal submission with leaf operation re-assigning.

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    Country specific rules

    Customizable validation rules to allow the preparation of eCTD submission specific to your country.

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    No extra server components are needed for the system.

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    Automated creation and packaging

    Auto creation and packaging of eCTD compliant electronic submissions.

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    Reuse previous sequences

    Automatic attribute and envelope / regional metadata elements generation from previous sequences.

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    Quick access buttons

    Commonly used tasks such as submission validation, document merging, adding PDF cross-references.

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    Envelope elements

    Easy country specific envelope creation.

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    Import / export files from SharePoint / Documentum

    Connect to your prefered DMS.

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    Share / collaborate your eCTD compilations

    Submit faster in teams - merge compilation from your team members.

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    Create pCTD from eCTD

    Quick conversion of an electronic submission to paper.