eCTD Dossier Life cycle and Query Management
eCTD Dossier Life cycle & Query Management
nPeople eCTD Manager solution is a powerful and easy to use software. You don't need to be an expert for using this inovative product. It is designed for regulatory submissions and managing dossier Documents & Submission life cycles. Its in-built validator ensures that the compiled eCTD dossier is compliant with ICH standards (M2 to M5) and regional standards (M1).
nPeople eCTD Manager software is fully validated and international regulatory compliant software. It is available as an independent product and can also integrated with our other eCTD products including nPeople SPL. We are one of the best eCTD Dossier Submission software and service provider in india.
- Build, view, validate and publish compliant submissions based on CTD, eCTD etc. submission structures easily.
- Detect and correct broken hyperlinks to create high-quality eCTD dossier.
- An integrated validation function ensures compliance of the submissions to ICH and regional specifications.
- Fully compliant to 21CFR Part 11 electronic submission guideline
- It makes eCTD life cycle management easier
Tags: eCTD dossier submissions , CTD & eCTD Submissions , Regulatory compliant dossier Submissions , US FDA Submissions , EMEA Submissions , ANDA submissions , Regional (Canada, EU, US) support , Electronic Common Technical Documenr (eCTD), CTD Format eCTD Dossier Format & Structure eCTD Dossier Preparation & Submission Service
- CTD/eCTD Dossier Preparation & Validation
- Compilation of dossier (eCTD/eDMF/NDA/AND)
- End-to-End Regulatory Consulting Services
- Reply to regulatory queries
- City: Mumbai (India)
- Phone: +91 87 939697 22
- : +1 949-632-1684
- Email : email@example.com