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 latest 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.