Human medicinal products and vaccines

Billev Pharma has for several years assisted companies with applications for registration of medicinal products for human use.

Regardless of the procedure type: National, Mutual Recognition (MRP), Decentralised (DCP), electronic (eCTD, NeeS) or by paper we have years of experience to be utilized.

As will be well known most companies have great backlogs when it comes to maintenance and compliance of registered products and their files.

We assist several of our clients with total overhaul of these matters enabling companies to concentrate on other aspects of regulatory affairs. At the same time, we help with strategic planning of the full product portfolio maintenance for these companies.

Human medicinal products and vaccines


We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier. 


We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.


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

Simple solutions in a complex PV environment

We are happily handling an increasing number of pharmacovigilance responsibilities for our clients in a complex pharmacovigilance environment. Our team of pharmacovigilance experts is now organised in three different fields – Human Accounts, Veterinary Accounts, and...

Dyrlæger i life science

I det nyeste nummer af Pharma kan du læse om vores kollega Charlotte Lindorf Eriksen og hendes arbejde med pharmacovigilance som dyrlæge i Billev Pharma Pharma nr. 3 2023—Side 14 ( Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...