Since the early 1990s we have assisted in a multitude of European procedures (MRP/DCP/CP). We provide all parts of applications from full procedure to parts – all in acceptance with the need of our clients.
For those clients still having files following the Notice to Applicant format we assist with the conversion into the Common Technical Document (CTD) format.
As the electronic CTD – eCTD – is mandatory in many of the procedures and in some countries, we assist with the conversion into the eCTD format making sure that your file is ready for future submissions.
We have the tools and knowledge available to assist with electronic applications.
As to the veterinary medicines industry we are able to assist with regulatory work also electronically using the VNeeS format.
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...