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 June 2018 Karen Jensen, M.Sc. Pharm., joined our regulatory team. Karen and our regulatory team can assist you with both European and national initial MAAs or maintenance activities. Karen is a generous co-worker...
In 2018 we celebrated Billev Pharma’s 40 years anniversary and also 3 times 10th anniversaries. Mette Skaarup Pedersen has been with us since 2008. Mette’s key area is proofreading and translation. Mette is highly...
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