Our highly experienced team of regulatory affairs and documentation professionals provides a comprehensive set of services that covers all aspects of the electronic drug regulatory affairs business.
It includes electronic submission services like eCTD or NeeS compilation, submission hosting, individual processing of submission documents as well as consultancy in all questions of electronic drug regulatory business.
In addition to our electronic dossier services we support the registration of your medicinal products in xEVMPD in acc. to Article 57(2) second subparagraph of Regulation 726/2004.
We also provide consulting and training regarding eCTD and xEVMPD requirements and support the implementation of electronic submission and tracking systems and their related business processes in the global pharmaceutical industry.
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