Telephone: +44 (0)1223 750638
In December 2008 the EMEA published a press release in which they state:
"From 1 January 2010, the EMEA will mandate the use of eCTD format for all electronic-only submissions for all applications (new and existing) and all submission types. Rapporteurs and CHMP members will not receive paper copies or other electronic formats."
eCTD is already mandatory in America (FDA) and the Czech Republic with many other countries strongly recommending its use.
The advantages of eCTD are:
Our professional associates use state-of-the-art publishing software and have published numerous electronic submissions in eCTD and non-eCTD electronic submission (NEES) formats ranging from Clinical Trial Applications (CTAs) to full Marketing Authorisations (MAs). If you don’t have the resource for eCTD publishing and Life Cycle Management in-house, please be assured that Global Regulatory Services can provide you with the appropriate support, expertise and technical know-how.
Please contact us with your specific eCTD regulatory compliance requirements.
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Telephone: +44(0)1223 750638