We continually monitor developments ensuring we are at the forefront of the latest electronic submission requirements of different authority. As per your requirement, we can prepare for your MAA application or and life-cycle maintenance activity i.e. variation or renewal;
Administrative and formatting services: document formatting (MS Word, PDF and etc.), scanning of paper documents, OCR, bookmarking and hyperlinking, preparation of media, validation, eCTD compilation and publishing.
We submit our applications via CESP or other Competent Authority portals to ensure courier costs are maintained as low as possible for you.
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.
All other authorities are updating their guideline and making eCTD compulsory for submission. We can provide you eCTD service as best price.