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eCTD Global has robust and fully compliant pCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

As a Pharma Industry expert, we are aware that most of the countries are slowly moving towards the paperless dossier/submission.

This change shows the transformation of the pharmaceutical industry to comply with regulatory requirements (submission in electronic format either in pCTD, in NeeS and/or in the eCTD format as per the health authority requirements) and to make avail drug products on time to the consumer.

eCTD Global support for dossier/submissions in non-regulated/semi-regulated/ROW countries i.e. ASEAN, CIS, AFRICAN, LATAM, MENA region, pCTD Suite is fully compliant with;

  • Common Technical Document (CTD) Format
  • ASEAN Common Technical Dossier (ACTD) Format
  • Country Specific/Region Specific Format

pCTD Suite

has in-built capabilities to perform;

Submission Management;

  • Data/documents collection through DMS Repository
  • Project micro-management with gap analysis
  • Track and maintain submissions timelines through Global Submission Schedule (GSS)
  • Archival of Dossier and Acknowledgement and Approval Letter in in-built repository

Document Level Publishing (DLP);

  • Word to PDF conversion/formation
  • Insert, replace, edit, delete, extract, split and OCR pages
  • Auto Bookmarking and intra-document hyperlinking
  • Toc generation, page numbering with header and footer

pCTD Level Publishing (SLP);

  • Country-wise pre-defined pCTD template
  • Assign docs to pCTD Suite with robust Volume Conversion
  • Generate CTD ToC and Module-wise ToC with Section Page
  • In-built CTD ToC/file-folder/single file creation with header & footer

pCTD Suite Features