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    Dossier preparation

    Successful registration that results in the granting of a Marketing Authorisation (MA) is primarily dependent on the quality of the product dossier that is assessed by the Competent Authority. SciencePharma offers full support in completing the documentation in the appropriate format such as electronic Common Technical Document (eCTD) format.
    Our service of dossier preparation includes all five modules:

    • Module 1 – Regional Administrative Information containing among the others Module 1.2 Application Form,
      Module 1.3 Product Information, Module 1.5 Specific Requirements for Different Types of Applications ,
      Module 1.6 Environmental Risk Assessment (ERA), Module 1.7 Information relating to Orphan Market Exclusivity
      and Module 1.8 Information relating to Pharmacovigilance
    • Module 2 – Overviews containing summaries on quality (QOS), non-clinical and clinical part of dossier
    • Module 3 – Quality
    • Module 4 – Non-clinical study reports
    • Module 5 – Clinical study reports.

    Our experts have extensive experience in the field of verification and preparation of documentation for medicinal products.
    In the process of dossier preparation, we are in constant contact with both the marketing authorization holder and manufacturers, realizing how important this communication is to ensure that the information presented in the dossier is correct and sufficient for the evaluating bodies.
    At the beginning of our cooperation, we become your active partner and will always try to find the best solutions!

    Veterinary medicinal products (VMPs) are a separate issue and the mandatory dossier format in case of VMPs is VNeeS (Veterinary eCTD electronic Submission) format. VNeeS format is mandatory for submissions to EMA as well as for submissions in the Decentralised, Mutual Recognition and National Procedures.

    The difference between eCTD and NeeS is that NeeS is essentially a collection of files organized in a series of folders. eCTD, on the other hand, is a more powerful option, facilitating easy dossier and lifecycle maintenance and navigation via an xml backbone.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.