Contact-us: + 33 1 69 59 23 00 HOME COMPANY “EXPLOITANT” SERVICES ... 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 Our network A few links Medipha Santé © 2018-2021 · Legales notices Ce site n\'utilise pas de cookies. This website doesn\'t use cookies. French regulatory affairs specialist Médipha Santé : all the skills of an « exploitant » !

Contact-us: + 33 1 69 59 23 00 HOME COMPANY “EXPLOITANT” SERVICES ... LEGALES NOTICES Our network A few links Medipha Santé © 2018-2021 · Legales notices Ce site n\'utilise pas de cookies. This website doesn\'t use cookies. French regulatory affairs specialist Médipha Santé : all the skills of an « exploitant » !