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 our 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.

Read more about the history of Billev Pharma.