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.
Frequently Asked Questions
eCTD submission-level publishing involves compiling, organizing, validating, and preparing regulatory documents for electronic submission to health authorities. It ensures that all documents, metadata, and submission sequences meet applicable regulatory and technical requirements.
Masuu supports pre-approval submissions, including original applications and amendments, as well as post-approval submissions such as supplements, variations, and reports. Our services cover all countries that accept eCTD submissions, with publishing tailored to regional requirements.
Our services include submission creation, document uploading, metadata preparation, STF creation, external hyperlinking, compilation, validation, verification, and dispatch. We manage each stage systematically to support accurate, compliant, and timely submissions.
Yes, Masuu supports the conversion of NeeS and paper-based submissions into eCTD format through baseline creation. This process involves organizing existing documents, preparing the eCTD structure, and validating the output against applicable technical requirements.
Masuu uses its NextGen eCTD publishing software to manage document lifecycle operations, including New, Append, Replace, and Delete. These operations maintain document traceability and consistency across submission sequences throughout the product lifecycle.
A Study Tagging File (STF) provides additional information about clinical and nonclinical study documents that may not be captured in the eCTD backbone. It includes details such as study title, study ID, category, site identifier, and file tag elements to improve document organization and review.
Yes, Masuu’s subject matter experts create STFs for Module 4 and Module 5 documents, including Clinical Study Reports (CSRs), Case Report Forms (CRFs), and datasets. This helps organize study-related information and supports compliance with applicable submission requirements.
Masuu’s publishing team manages external hyperlinks between related documents and compiles the eCTD XML output using a structured review process. Each link and document placement is verified to support accurate navigation, consistency, and regulatory compliance.
Masuu uses project-specific eCTD trackers to monitor file naming, leaf titles, external links, metadata, and lifecycle operations. Detailed change history records provide visibility into document updates and support traceability throughout submission preparation.
Masuu assigns dedicated country-specific and client-specific regulatory operations professionals to manage submission activities. Combined with advanced publishing tools, structured validation, and quality reviews, this approach helps minimize technical deficiencies and supports timely submission dispatch.