Masuu provides expert guidance and support for eCTD Publishing and Conversion, ensuring smooth planning and management throughout your product’s lifecycle.

Our comprehensive services include:
  • Tailored Submission Advice:
    We offer customized guidance on submission attributes, gap analysis, and lifecycle operations (new, replace, append, and delete), ensuring all regulatory requirements are met.
  • Planning and Coordination:
    Masuu SMEs plan, coordinate, and collect documents from the client cross functional teams for eCTD publishing activities.
  • Meticulous Document Tracking:
    Utilizing eCTD checklists with Regional and ICH metadata, we meticulously track documents to ensure compliance and readiness for submission.
  • Expert eValidation Troubleshooting:
    We excel in identifying and resolving eValidation issues, ensuring strict adherence to health authority requirements.
  • Qualified Regulatory Operations Professionals:
    Our team provides end-to-end publishing support, delivering timely and high-quality submissions without eCTD-related deficiencies.
  • NextGen PDF Toolbox and eCTD Software:
    We leverage industry-leading tools like NextGen PDF Plugin and eCTD software for efficient regulatory submissions in eCTD format.
  • Client-Centric Approach (Country and Client-Specific Focus):
    Masuu adopt a tailored approach, prioritizing global standards while providing document-level and submission-level publishing services.
  • Rigorous Quality Control:
    Our expert team conducts multi-stage verification and reviews to guarantee accuracy and compliance.
  • Handling Last-Minute Changes:
    Our team efficiently manages last-minute changes, ensuring smooth transitions without compromising quality.
  • Staying Updated:
    We continuously update our internal processes and website blog to keep clients informed of the lawww regulatory requirements and best practices.
  • Comprehensive Support:
    Masuu offers 24/7 client support, providing reliable and confidential eCTD Publishing and Submission assistance tailored to your needs.
  • Road Map Preparation:
    Prepare and update the project road map, maintaining full awareness of all ongoing regulatory activities through constant project micro-management.
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