Billev Pharma ApS is a Danish consultancy company within the international pharmaceutical and medical field.

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Simple Solutions in a Complex Environment

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

CP approval granted exceptionally fast
CP approval granted exceptionally fast
Trine Fabricius Holm has been with us for 2 years now working as a Regulatory Affairs Manager. Trine has more than 20 years of experience with national and European procedures, referrals and regulatory strategies...
Top-notch medical translation is our thing!
Make sure to let us handle your translations – that is, if you want to save time and money without compromising quality. High-quality translations make your way through the marketing authorisation process so much...
Let us handle your medical translations!
Let us handle your medical translations!
Medical translation requires a mastery and knowledge of the medical field. The specific terminology and compliance with the current regulation is unique to the industry – something we specialize in. It’s important that your...