E-only, the paperless submission, has come within reach in the field of regulatory affairs.
The implementation of the European requirement is a major challenge, i.e. continuing to manage previous paper-based documents in electronic structures in the future.
We routinely perform conversions of paper dossiers (also in NTA format) to the CTD, NeeS and eCTD structures. We draw upon our regulatory expertise in this process.
We digitise not only individual dossiers, but also entire archives.
We have the necessary infrastructure to store and scan large numbers of folders and documents.
We coordinate translations of dossiers in consultation with external partners.
We have been working with our eCTD Manager since 2006, and have seen all phases of the development of this software solution.
With the help of our Extedo licence, we generate sequences which are ready for submission and conform to the specifications in an straightforward and timely manner, regardless of whether they are so-called baselines, new registrations or the maintenance of marketing authorisations. You will not incur any costs for the acquisition of the system, nor any follow-up costs for system maintenance, hardware, technical support or training.
We create NeeS sequences for you in the same way.
We are also happy to assist you with submissions.
On request, we also provide long-term storage of your electronic dossiers on our company owned server (data hosting).
Our service for esubmissions includes:
We take over the submissions required for your products and your organisation and manage your Article 57 databases – also in cooperation with your EU- or national QPPV and your Regulatory Affairs Department if desired.
SPOR and IDMP are also part of our spectrum.