eCTD Management: Life cycle of your marketing authorisation

eCTD Management: Life cycle of your marketing authorisation

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Medipha Santé works with Extedo’s eCTD Manager software, a software used by more than 35 regulatory authorities, which offers a complete solution for managing and assembling regulatory files.
In order to ensure compliance with regulatory requirements, eCTD management allows us to maintain a complete overview of the submission status for a number of products in several different geographic markets.

With eCTD management we offer you the possibility to:

  • Create eCTD sequences
  • Submit to the French and European and US authorities (more than 200 dossiers submitted per year and evaluated by more than 25 agencies)
  • Ensure the evaluation of the file during the procedure (additional file, admissibility, answers to IM and PR, answers to questions at the various stages of the calendar…)
  • Submit post-AMM requests (modification requests, renewals, etc.)
  • With eCTD management we can visualize, validate and publish eSubmissions that comply with ICH and regional specifications.

We also propose:

  • Creation / publishing / formatting eCTD / NeeS / working documents
  • eCTD / IMPD / non-eCTD Dossier
  • EU eCTD / US eCTD / GCC eCTD / CA, JP, HR, etc.
  • AMM / CTA / ASMF / initial application, amendment, RtQ, variations, etc.
  • Baselines eCTD (with gap analysis / roadmap, QC review)Pre-publication quality control
  • Creation of intra/extra document hyperlinks, metadata management
  • Technical validation against international, regional and local specifications (eCTD / NeeS validation tool)
  • Submission via member country portals, CESP, eSubmission Gateway, (CESSP) etc.

The advantages of eCTD management:

  • Rapid compliance with the latest regulatory developments worldwide
  • Ability to validate and publish submissions from a single application
  • Improves the quality and consistency of the submission
  • Handles the publication of electronic and paper submissions in structures and formats for all regions of the world
  • Prepared for future standards such as eCTD 4.0 (RPS)
  • Compliant with ICH and regional file names and 21 CFR Part 11