We can help you to prepare your submissions in eCTD and submit them to the relevant agencies on your behalf. Acorn Regulatory manages the electronic submission process for a large number of clients.
Overview of eCTD
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. eCTD electronic submissions were first accepted by the European Medicines Agency in 2003. As part of the EMA’s move to an electronic submission system, they no longer accept paper-based applications for products applying to the centralised procedure. Since January 2016 all electronic submissions must be in the eCTD format.
How We Can Help You
At Acorn Regulatory, we can assist you by working with you in building your submission package in eCTD (or NeeS) and submitting these to the national competent authorities (NCA) either by CESP or through the national portals as appropriate. We have local partners across Europe ensuring all local requirements are fulfilled. Our experts can help you if it’s a new marketing authorisation application (MAA) or a variation as we have the right expertise in-house to ensure your submission is submitted successfully and on time.
At Acorn Regulatory, we have been using Extedo software since 2011 and have built up significant experience working with our clients supporting them with their submissions and ensuring they understand what is required to achieve a successful validation.
Time and again, clients call upon our electronic submission expertise.
If you have a query about electronic submissions or eCTD then talk to us today. Call us on 00353 52 61 76 706, email us: firstname.lastname@example.org or complete your details below and we will get back to you.