eCTD and NeeS Compilation

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. Our team is are fully prepared for new requirement, to provide services using eCTD format. The requirement will come into force in 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, 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.