CH eCTD Compiler

CH eCTD Compiler - Swissmedic eCTD

CH eCTD Compiler, a part of eCTD Office, is an eCTD validation, creation, manipulation, viewing and publishing system for Swissmedic electronic submissions for human medicinal products.

eCTD Office produces valid Swissmedic eCTD electronic submissions.

Fully compliant with Swiss Module 1 Specification

The main functionality of the CH eCTD Compiler is the creation of valid Swissmedic electronic dossier submissions along with the lifecycle management.

By using the CH eCTD Compiler and its change control process, several topics including regional-aware approved template, lifecycle management, attributes, granularity, galenic forms and envelope values are addressed and solved.

Built in validation supporting regional rules ensures no invalid submissions can be generated.

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

Mono eCTD Office's eSubmission Compiler Main Features

  • Icon

    Affordable

    Save time and money with your next submission!

  • Icon

    Understand eCTD

    Complex XML and other IT related features hidden from you!

  • Icon

    Create valid eSubmissions

    Embedded Validation Criteria.

  • Icon

    Create eCTD templates

    Speed up your work, create pre-populated compilations.

  • Icon

    Convert MS Word to PDF at publishing

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

  • Icon

    Split / merge PDF documents

    Easily combine several PDF documents for a single published document.

  • Icon

    Create / auto-correct PDF hyperlinks

    Ensuring your PDF hyperlinks are valid and functional.

  • Icon

    Powerful PDF processing features

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

  • Icon

    Intuitive Interface

    Easy-to-use intuitive user interface.

  • Icon

    ASMF submissions

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

  • Icon

    Automatic MD5 checksum generation

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

  • Icon

    Automated optimization

    Automatic optimization: removal of orphaned files and empty sections.

  • Icon

    In-place validation

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

  • Icon

    Region-specific

    More than 250 ICH and specific regional validation rules.

  • Icon

    Document merging

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

  • Icon

    Country specific rules

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

  • Icon

    Off-the-shelf

    No extra server components are needed for the system.

  • Icon

    Automated creation and packaging

    Auto creation and packaging of eCTD compliant electronic submissions.

  • Icon

    Reuse previous sequences

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

  • Icon

    Quick access buttons

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

  • Icon

    Envelope elements

    Easy country specific envelope creation.

  • Icon

    Import / export files from SharePoint / Documentum

    Connect to your prefered DMS.

  • Icon

    Share / collaborate your eCTD compilations

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

  • Icon

    Create pCTD from eCTD

    Quick conversion of an electronic submission to paper.