eCTD CompilationElectronic respectively eCTD submissions are increasingly recommended - and requested. Almost all EU/EEA drug regulatory agencies are accepting now electronic only submissions for medicinal products for human use and are recommending the eCTD as the preferred standard (see our News).
If you would like to focus more on the contents of your submission rather than spending many resources on the technical requirements, then you need a reliable and experienced partner that delivers compliant high-quality eCTDs always in time:
- We create and submit your eCTDs (or NeeS) for EU, USA, Canada, Switzerland, Australia and other regions for all registration procedures and product types
- We manage your complete eCTD lifecycle (see also our “submission hosting” service)
- We provide Study Tagging Files (STFs), Structured Product Labeling (SPL) and CRF bookmarking and hyperlinking (US)
- We support your Product Information Management PIM (EU)
- We support you at pre-submission meetings
- We comply with the latest regulatory requirements and agency recommendations
- We assure meeting even the most challenging submission deadlines
Please note that will also offer in-house eCTD compilation support in case of manpower shortages! 
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