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.
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
En inspirerende teamdag
Hvordan kan det være, at nogle ser begyndelser (bryllup), mens andre ser slutninger (begravelse), når 4 sorte limousiner kommer kørende i kortege på tværs af vejen? Kan du lære at holde hovedet, håbet, humøret & modet oppe? JA, vi nåede 9 opbyggelige øvelser på 5...
Are you lacking the capacity or qualification to perform an audit?
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...
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...