eCTD & SPL

The electronic common technical document (eCTD) is an interface and internationalspecification for the pharmaceutical industry to agency transfer of regulatory information. It is the standard format for submitting applications, amendments, supplements, Variations and reports with XML backbone to the regulatory agencies like US FDA-CDER, CBER, European health authorities, Canada, GCC, South Africa, Australia, Thailand for ease of review and navigation through the submission. Many counties are still working to adapt the eCTD formats for submission like china and many more.

We at NUVO, can help you with writing all the modules of the applications from Module 1 to module 5 for the drug product and drug substance as per regulatory requirement and support the complete eCTD publishing activity and its submission to health authorities. NUVO as your regulatory Partner shall take care of all the requirements end to end without u having any software for the same.

Following are in brief support for eCTD services:

• eCTD Compilation, QC Review, Technical Validation and Submission Hosting
• eCTD Lifecycle Management
• Baseline eCTD : Dossier conversion from Paper/CTD/NeeS to eCTD.
• Importing and Cloning of Existing eCTD Applications
• US FDA
  • ANDA Dossiers – Module 1 to Module 5
    • 505j
    • 505(b)(1)
    • 505(b)(2)
    • SPL
  • SANDA Dossiers
  • DMF Publishing– Module 1 to Module 3
    • Type-II DMF – API, Intermediate and semi-finished formulation
    • Type-III DMF – Packaging
    • Type-IV DMF – Excipients
  • Life cycle Management
    • Amendments,
    • Annual updates,
    • Query responses
    • Request to information etc.
    • Post approval changes
      • CBE0
      • CBE30,
      • Prior Approval Supplement (PAS)
• European Dossiers(EU): – Module 1 to Module 5
  • MAA Dossiers for
    • • National Procedure
      • MRP – Mutual Recognition Procedure
      • DCP – Decentralized Procedure
  • DMF(Drug Master File)– Module 1 to Module 3
    • ASMF – Active Substance Master File
    • CEP – EDQM
  • Life cycle Management
    • Query responses,
    • Renewals,
  • Variations
    • Type – I
      • Type – IAIN
      • Type – IA
      • Type – IB
    • Type – II
• GCC: Baseline publishing, New Dossiers, Query responses, Renewals, variations etc.
• Health Canada, AU-TGA, MCC-ZA, Thailand (ASEAN), ROW:
  • • Dossiers
    • DMF
    • Query responses
    • Renewals
    • Variations
• Pdf publishing:
  • • PDF – Ready for Submission,
    • Bookmarking,
    • Hyperlinking,
• Additional support :
  • • OCR (Optical Character Recognition),
    • Embed Fonts,
    • Compliance with Regulatory Requirements
    • NeeS – Non-eCTD electronic Submissions
• NeeS– Non-eCTD electronic Submissions, we can support with publishing of NeeS DMF and Dossier for submissions
• China – Work in progress