Registration

National registration
MRP/DCP/CP registration
Electronic submission
Human medicinal
products and vaccines
Veterinary medicinal
products and vaccines
Herbal medicinal products  

Pharmacovigilance


Translations


Clinical Trials


Qualified Person


MRP/DCP/CP registration

Since the early 1990s we have assisted in a multitude of first MRPs and then DCPs throughout Europe.

We provide all parts of applications from full procedure to parts– all in acceptance with the need of our costumers.

For those customers still having files following the Notice to Applicant system we assist with the conversion into the Common Technical Document (CTD) system.

As the electronic system - e-CTD – is optional in most countries from January 2010 and mandatory in some countries we have the tools and knowledge available to assist with such applications.

As to the veterinary medicines industry we are able to assist with regulatory work and in the future also electronically using the VNeeS procedure.

Billev Pharma ApS        Elmegaardsvej 1A, Toerslev        3630 Jaegerspris        Telephone: +45 47 52 26 00        E-mail: