We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Our staff has experience from originator companies as well as from the generic industry and medicinal authorities. For details please see the Billev Pharma team. There are different ways of licensing medicinal products in EU:
- National procedure followed by the Mutual Recognition procedure (MRP) if a marketing authorisation is desired in more than one member state.
- Decentral procedure (DCP) if a marketing authorisation is desired in more than one member state.
- Central procedure (CP) if a marketing authorisation is desired in all member states.
Which procedure to use depends on the strategy – we can help in this process by giving details on each procedure and outlining the differences.
National registration »
MRP/DCP/CP registration »
Human medicinal products »
Veterinary medicinal products »
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
We are equipped to assist with any type of electronic submission and maintenance of your electronic file.
Special medicines areas
Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.
GDP & GMP Services
We offer full time and part time responsible person (RP) function and qualified person (QP) function.
Latest News
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