Billev Pharma is a small independent Danish consultancy company occupied primarily within the fields of regulatory affairs and pharmacovigilance.
Our multi-skilled staff assist with a variety of approaches to regulatory affairs and pharmacovigilance. We provide our clients with a quick but critical way to gain authorisation and maintenance of their products on the European market.
With our many years of experience in this field, we cover most areas of the pharmaceutical sphere such as regulatory affairs and pharmacovigilance for human medicines, veterinary medicines and herbal medicines. In addition, we offer services within quality control and quality assurance.
As can be seen from the CVs of Billev Pharma staff a broad range of experience enables us to assist in all types of procedures.
As Regulatory Affairs are becoming more diversified, it is important to have a staff with wide experience in all aspects of the field from classical pharmaceutical knowledge of chemistry, manufacture and control, over biochemistry to pharmacovigilance and language skills.
Billev Pharma was one of the first movers in providing assistance with all new application types starting with national applications all over Europe to MRP, DCP and now e-CTD.
We continuously work to influence legislation through active involvement in professional organisations (Medicines for Europe etc.). We develop our means to reach our goals by using and developing the most up to date solutions and tools for the benefit of our clients.
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.
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.
At Billev Pharma we have a team of qualified lead auditors within GVP, VGVP, GMP and GDP. Last year our audit team conducted more than 10 remote pharmacovigilance audits and 10 onsite GDP audits of warehouses. We conduct remote and onsite audits within the EU as well...
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...
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 (ipaper.io). Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...