eCTD Dossier Submissions, Dossier Submission
eCTD Dossier Submissions
We help pharmaceutical companies in construction / Preparation of complex dossier technical documents ( eCTD ) for electronic Submission. The produced eCTD dossiers are fully validated and international regulatory compliant. We provide quick and intuitive construction of complex eCTD submission for any regulatory authority.
nPeople is one of the software vendors who provides effective consulting at each step of eCTD Dossier submission process. We have considerable number of successful submission of eCTDs dossiers at US FDA and EU EMEA. Our constant consultancy makes your submissions furthermore easy.
nPeople eCTD consulting team has extensive experience of supporting small and medium-sized biotechnology companies in building a well-designed eCTD Dossier.
eCTD Dossier Submission Services
We offer the following regulatory operation services to ensure regulatory compliant eCTD Dossier submissions:
- Document's granularity and life cycle management
- Submission roadmap / structure creation in CTD / eCTD format
- Dossier assembly and compilation in eCTD format
- Work in progress / Internal/ Final review
- Sequential / Parallel approval cycles
- eCTD Dossier Compilation , Publishing , Archiving and Submission
- Seamless collaboration between all key stake holders of a drug submission including author / assembler, reviewer, approver and publisher.
- Conversion of Paper based submission to Electronic document as required by international regulatories
- Electronic Submissions gateway setup and administration
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