pCTD Compiler

pCTD Compiler - Hardcopy Publishing

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 hard copy - paper based version supporting generation of volumes, tab sheets and an overall table of content based on the dossier hierarchical structure.

While Agencies accept electronic submissions such as NeeS and eCTD (human products) or VNeeS (veterinary products) they still might require you to send sections of your dossier in hardcopy / paper format.

pCTD Compiler was developed to ease the process of "converting" an electronic submission to its paper counterpart.

pCTD Compiler generates, for the hand picked selected electronic documents, a single volume (per module or part) PDF documents having all documents merged and separated using tab sheets - to be easily stored in ring binders.

eCTD Office's pCTD Compiler main features

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    No Adobe Software Required!

    pCTD Compiler does not require Adobe Acrobat software.

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    Highly configurable

    unlimited list of pre-defined volume generation options.

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    Preview volumes

    Quickly preview volumes content before the final publishing.

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    TOC generation

    Generation of the overall table of contents for the pCTD dossier.

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    Add heading pages

    Separate documents using tab sheets for CTD heading sections, document titles and node extensions.

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    Split large volume documents

    Auto split large documents into several volumes using pre-defined maximum page size for a volume (+ manually fine tune page breaks).

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    Fine tune page breaks

    Manually specify page break for larger volumes.

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    Custom cover/tab pages.

    Define custom header/footer values for documents and tab sheets.

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    Volume pagination

    Define unified custom volume pagination.