Vigilex Xendo DeutschlandXendo Deutschland

florian"eCTD is a simple technology. But it has such a tremendous impact. I always enjoy having the entire dossier and its history at my fingertips."

Florian Pöll, Consultant Regulatory Affairs

E-Submissions

The EMA/HMA e-submission roadmap has now made eCTD mandatory from 2017 on - for all human CP, DCP and MRP submissions. It is highly likely that national submissions will follow soon. Moves beyond eCTD are planned and will result in growing e-submission requirements, such as IDMP reporting.

For us, e-submissions are not only requirements one has to comply with. They are tools to optimize compliance and regulatory productivity which can be fruitfully integrated into your internal processes. Based on your business situation we will develop an e-submission strategy that suits your needs.

Our services include the following formats:

eCTD and NeeS/vNeeS and EVMPD/IDMP and CTA/ICSR

 

With our new eCTD service-product Reg 48 we assure, that

  • you get a published dossier within 48 hours
  • for a fixed rate
  • including a Regulatory plausibility check

 

Reg48 is a reliable e-submission service

  • Developed with a view on your deadlines
  • Delivered by people who know Regulatory inside out
  • Designed for either a quick fix or a long-term partnership 

Contact us at: office.de@xendo.com