eCTD Management: Life cycle of your marketing authorisation
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