eCTD & NeeS Compilation
Biomapas provides 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. Our team is fully prepared for new requirements and to provide services using the eCTD format. Such a requirement came into force on the 1st of January, 2018.
Full scope eCTD and NeeS services include:
- A full dossier review and eCTD publishing services;
- Assessment of old dossiers, gap analysis, updates of the 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;
- xml formation required for EAEU;
- Managing the life cycle of your product(s).