The requirements to the documentation for the registration of veterinary medicinal products have been tightened over the years and are now as strict as for human medicinal products.
As each species must have its own clinical coverage and animals for human consumption must be covered for MRL (maximum residue level), the requirements are even stricter in some respects.
We have dealt with new products as well as with generics covering veterinary vaccines, veterinary pharmaceuticals, animal feed, food supplements and biocides.
The CTD format is not applicable for veterinary medicinal products and the Notice to Applicants format is still in use.
The electronic format VNeeS has been development and is already in use in many of the procedures and in most countries. We can also assist with electronic submissions as we have the necessary software in house.
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...