Billev Pharma ApS is a Danish consultancy company within the international pharmaceutical and medical field. |  |
Simple Solutions in a Complex Environment |
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Billev Pharma ApS was set up in 1978 as the first company of its kind in this part of Europe. We assist the pharmaceutical industry mainly with the registration of medicinal products and pharmacovigilance.
We help with the solving of several small and big problems in situations where the companies in question either have no specialised staff or periodically have too little capacity. Over the years we have had the opportunity to assist with a multitude of assignments ranging from national registrations over the Mutual Recognition to Decentralised and Centralised procedures.
Today we are equipped to assist with any type of electronic submission (e-CTD, NeeS, VNeeS). We work equally with the registration of human medicines, veterinary medicines as well as immunological products for both human and veterinary use.
Latest News
In May Mette Olsen, M.Sc. Pharm., joined our regulatory team. Mette has more than 10 years’ experience handling EU procedures. She also has experience with Pharmacovigilance and Marketing Compliance. Mette has vide experience working...
and our team working with preparation and review of analytical and pharmaceutical documentation is growing. In May Lone Pallesen, B.Sc. Ing. in chemistry joined our regulatory team. Lone holds a Diploma in Regulatory Affairs...
In February Trine Fabricius Holm, M.Sc. Pharm., joined our regulatory team. Trine has more than 18 years of experience working as a Regulatory Project Manager from the Danish Medicines Agency. Trine has wide experience...