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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).

All Marketing-Authorization Services

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