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."
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 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