eCTD Submission Level Publishing : Masuu’s expert team and advanced tools ensure your submissions are compliant, timely, and of the highest quality, providing peace of mind and regulatory success.

Our comprehensive services include:
  • Comprehensive eCTD Submissions:
    Our team assists clients with all types of eCTD submissions, including Pre-approval (Original Applications and Amendments) and Post-approval (Supplements, Variations, and Reports) for all eCTD-accepting countries.
  • Submission Creation and Management:
    We support the pharma and healthcare industry with submission creation, document uploading, STF creation, external linking, compilation, validation, verification, and dispatch to health authorities.
  • Dedicated Regulatory Professionals:
    We provide country-specific and client-specific Regulatory Operations professionals (Submission Level Publishers) to ensure tailored support.
  • Format Conversion:
    We convert NeeS and paper formats to eCTD format (baseline submission).
  • NextGen eCTD Software:
    We assign documents to our proprietary NextGen eCTD software (publishing tool) for life-cycle management, including New, Append, Replace, and Delete operations.
  • STF Creation:
    The eCTD backbone files do not contain enough information on the subject matter of several documents (e.g., study report documents). This additional information is provided in the STF (Study Tagging File). Masuu SMEs create a Study Tagging File (STF) for module 4 and module 5 (CSR, CRF and Datasets), which helps organize different clinical and non-clinical studies by providing additional heading elements and heading attributes such as Study Title, Study ID, Category, Site identifier and File tag element.
  • External Hyperlinking and Compilation:
    We handle external (inter-document) hyperlinking, compile, and publish eCTD XML output with a standard review process. Masuu SMEs team ensures that all documents are correctly linked and organized according to regulatory requirements.
  • End-to-End eCTD Tracking:
    We use project-specific eCTD trackers (file naming, leaf titles, and external links), metadata creation forms (regional and ICH metadata), life-cycle management (New, Append, Replace, and Delete), and change history documents to monitor the entire submission publishing process.
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