Deadline January 1, 2019: eCTD mandatory for all submissions in the EU!

Are you prepared? You do not want to buy the necessary eCTD software yourself?

We are happy to assist you with the implementation of your submissions.

• Processing of your registration documents with regard to technical quality and optimized navigation (Submission Readiness),
• Planning, creating, publishing and submitting your eCTDs for new registrations, baseline submissions and variations,
• Takeover of the eCTD Lifecycle Management,
• Transfer of existing paper or NeeS dossiers to the eCTD format,

We have the necessary software to create validated eCTD sequences in the EU and elsewhere. Thus, you have no system acquisition costs and no follow-up costs for system maintenance and technical support.

• High speed from the decision to the eCTD dossier
• You do not need technical support and maintenance personnel in-house
• You have no system responsibility for update and software maintenance and save the costs for hardware and training

Ask us today for a non-binding offer. You can concentrate fully on the technical content of the documentation again - we take care of the rest.

For more information visit our page: https://www.orangeglobal.de/ctd-dossier-en/

We are looking forward to your contact.