Team Masuu’s detailed and rigorous PDF process ensures that each document is thoroughly prepared, reviewed, and validated for eCTD publishing, meeting the highest standards of compliance and quality. This comprehensive approach supports pharmaceutical and healthcare clients in navigating the complex regulatory landscape effectively.
Our comprehensive services include:
- Content Formatting:
Prepare documents in MS Word or other source formats, ensuring consistency in styles, headings, and sections. Apply predefined templates for uniformity and compliance with health authorities standards such as font size, font type etc. - File Conversion:
Convert formatted word documents into PDF format while maintaining structural integrity. This includes embedding fonts, setting security permissions, and optimizing the file size for efficient handling and submission. - Comprehensive Submission Documents PDF Processing:
Transform dossier documents into compliant PDFs with bookmarks, hyperlinks, Table of Contents (ToC), page numbering, Ctrl+D properties, OCR, and orientation adjustments, all adhering to global health authority requirements. - Initial QC:
DLP team will perform an initial quality check on the PDF for formatting issues, bookmark accuracy, and hyperlink functionality. This step often includes verifying the correct application of document properties (Ctrl+D properties) such as title, author, subject, and keywords. - Rigorous Verification Process:
Each document undergoes multi-stage and multi-level verification and review using the eCTD QC checklist by Subject Matter Experts (SMEs), ensuring quality and compliance before submission to the Submission Level Publisher (SLP) team. This includes checking for any missing information (figure, table, sections), incorrect formatting, tilted pages, orientation issues (portrait/landscape), or broken/inactive bookmarks and links. - Client Feedback Integration:
Ensure document updates align with feedback from the SLP team and clients, maintaining adherence to internal standards and regulatory guidelines. - Harmonized PDF Conversion:
Adhere to specific client requirements with pre-defined templates for eCTD, pCTD, NeeS, and Veterinary NeeS submissions, suitable for regions including the USFDA, EMA, MHRA, HEALTH CANDA, GCC, SWISS, TGA, TFDA, JFDA, SAHPRA, ECOWAS and emerging markets. - Dedicated Professionals:
Utilize country-specific and client-dedicated Regulatory Operations (eCTD Publishing) professionals for precision and consistency in document publishing. - Detailed Tracking and Documentation:
Maintain project-specific document tracking and detailed documents change history records to manage and monitor the entire publishing process. - Study Report Level Publishing (SRLP):
Team Masuu excels in supporting Clinical Study Reports (CSR) and Clinical Trial Authorization (CTA) activities. We follow client internal standards and agency requirements, providing reliable and consistent support throughout the Publishing process.