US eCTD Compiler

US eCTD Compiler - FDA eCTD Publishing

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

eCTD Office produces valid FDA eCTD electronic submissions.

Fully compliant with U.S. Module 1 Specification, version 1.3 (dtd 2.01) and 2.3 (dtd 3.3) and FDA eCTD Validation Criteria.

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

By using the US eCTD Compiler and its change control process, several topics including regional-aware approved template, visual STF builder, lifecycle management, attributes, granularity, and administrative 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 FDA / ICH eCTD specification.

Mono eCTD Office's eSubmission Compiler Main Features

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    Affordable

    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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    Region-specific

    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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    Off-the-shelf

    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.