You have to do something new to see something new.

Georg Christoph Lichtenberg

More and more international and national authorities demand the electronic submission of authorisation applications, variations, and pharmacovigilance data. To meet this demand, know-how is needed – and a suitable software solution.

We would like to offer you support for the preparation of eCTD dossiers and the implementation of electronic submissions. In cooperation with us you will comply with all legal requirements and recommendations.

 

  • Preparation of Documents and Electronic Submission
    • Conversion of all documents into suitable formats
    • Filling in forms and application documents
    • Internal quality control
    • Upload of all required data

     

  •   Creation of eCTD dossiers, including
    • Adaptation of documents to the electronic requirements
    • Reformatting of the complete dossier or of individual components, if necessary
    • Creating bookmarks and hyperlinks

  • Advantages of outsourcing and software sharing

    • No costs for system procurement
    • No follow-up costs for system maintenance and technical support
    • High speed from the decision to the eCTD dossier
    • No direct costs for software, licenses, hardware, system validation and maintenance, training courses

  • Disadvantages of an in-house solution

    • High costs for the purchase of a system
    • Long lead time for the implementation of a system
    • No system responsibility for update and maintenance
    • Technical support and maintenance personnel must be available
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Your paper-based dossier must be converted to an electronic version in CTD format.

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The digitized dossier parts are sorted into the specified eCTD structure by a suitable software and an xml backbone is created, so that the files can be read out electronically.

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The dossier in eCTD format will be sent to the authorities. This is mandatory from 1.1.2019 on all variations.

This post is also available in: German