Simple Solutions in a Complex Environment
Billev Pharma ApS is a Danish consultancy company within the international pharmaceutical and medical field.
What we do
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.
We work with registration of human and veterinary medicines including radiopharmaceuticals and biologicals and have the software to compile electronic submissions (eCTD and VNeeS).
Services
Registration
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
Pharmacovigilance
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
Translations
We offer high quality medical & pharmaceutical translations into and from several European languages.
Electronic submission
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.
Latest News
Do you need help with the Quality documentation (CMC) for your medicinal products?
We are a truly dedicated team, most of us with many years’ experience from the Danish Medicines Agency or headquarter of global companies in Denmark. We know exactly what it takes to Prepare CTD module 2 and 3 for applications for human medicines. Prepare part 2 for...
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 among others from the Danish Medicines Agency. Trine is...
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 smoother. Let our team of trained medical translators...