Welcome to Exalon

Your partner for high quality eCTDs, regulatory submission services and EVMPD support

Our highly experienced team of regulatory affairs, documentation and IT professionals provides a comprehensive set of services covering all aspects of the electronic drug regulatory affairs business.

We are publishing eCTD submissions for of all types of applications (e.g. medicinal product dossiers, master files) in all regions. Our services include submission hosting, processing of individual submission documents as well as consultancy in all questions of electronic drug regulatory business.

In addition to our electronic publishing services we support the registration of your medicinal products in xEVMPD in acc. to Article 57(2) second subparagraph of Regulation 726/2004.

We provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems in the pharmaceutical industry.

 

eCTD implementation

eCTD implementation Placeholder
eCTD implementation

Our Twitter Live Feed

Swissmedic issues update of Swiss #eCTD and eDok specification documents. eCTD v1.4 will be implemented starting 01-Jan-2019, mandatory use from 01-Jul-2019 onwards. https://www.swissmedic.ch/swissmedic/en/home/services/submissions/news-submissions/aktualisierungvonectdundedokvorgabedokumenten.html

"#Qatar, as part of efforts to achieve self-sufficiency in terms of necessary medicines, is expected to introduce the popular eCTD very soon..." industryhttps://www.thepeninsulaqatar.com/article/31/05/2018/Qatar-to-achieve-self-sufficiency-in-medicine-soon

Automation of validation of eCTD and NeeS sequences #Australia #TGA #eCTD https://www.tga.gov.au/automation-validation-ectd-and-nees-sequences#.WxUc-JDYTLE.twitter

Not a very wise move: #FDA Delays #eCTD Requirements for Master Files https://shar.es/1Q9gas

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