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).