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.

Billev Pharma ApS

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).

Billev Pharma Team »

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

En inspirerende teamdag

Hvordan kan det være, at nogle ser begyndelser (bryllup), mens andre ser slutninger (begravelse), når 4 sorte limousiner kommer kørende i kortege på tværs af vejen? Kan du lære at holde hovedet, håbet, humøret & modet oppe? JA, vi nåede 9 opbyggelige øvelser på 5...

Simple solutions in a complex PV environment

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...