Biomapas provides a full support in Electronic Common Technical Document (eCTD) compilation and submission, as well as Non-eCTD electronic Submissions (NeeS). We use the eCTD Office software.
Full scope eCTD and NeeS services include:
- A full dossier review and eCTD publishing services;
- Assessment of old dossiers, gap analysis, update of dossier to be compliant and ready for submission;
- Converting your documents into eCTD/NeeS format;
- Preparing the Dossiers in eCTD/NeeS for initial submissions/renewals/variations;
- Managing the life cycle of your product(s).
For any inquiry regarding our services, please contact Biomapas Business Development team.