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 Registration
Pharmacovigilance
Translations
Clinical
Trials
Qualified
Person
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Electronic submission
e-CTD, NeeS and Vnees.
From the New Year 2010 electronic submissions are mandatory
in a few countries, preferable in several countries and possible
in all European countries.
The actual situation changes from month to month. Billev Pharma
Aps follows this development closely and we are always fully
updated and can therefore give full support to our costumers.
Therefore, there is an uncertainty among applicants as to
what means to use and when to start.
With our inside knowledge we will be able to advise our costumers
on the most appropriate method and timeline for submission.
Billev Pharma Aps has invested in the necessary software in
order to be able to submit electronically.
We can assist with full files as well as file maintenance.
We can also provide parts of the files where that is feasible.
VNeeS will be the new system for veterinary
medicinal products. In this field, where e-CTD is
not used, the electronic submissions are already possible
in some countries.
Please contact us to hear more about the future systems for
submission of applications and for maintenance of the regulatory
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