Trine Fabricius Holm

Trine Fabricius Holm
M.Sc.Pharm., Senior Regulatory Affairs Manager

Trine Fabricius Holm holds a M.Sc. in Pharmacy from Copenhagen University and has been with Billev Pharma since February 2021 as a Regulatory Affairs Manager. As of March 2023 Trine will hold the position as Senior Regulatory Affairs Manager. 

Trine has more than 20 years experience within regulatory affairs incl. 18 years experience from the Danish Medicines Agency as a Regulatory Project Manager.  She has wide experience with national procedures, MR and DC procedures, renewals, referrals and other regulatory issues. At Billev Pharma Trine has gained regulatory experience with the Centralised procedure. 

Trine’s experience covers:

  • National and DC procedures
  • Centralised procedures
  • Product information updates
  • Product life-cycle maintenance
  • eSubmissions
  • Regulatory strategies


We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier. 


We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.


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

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...

Dyrlæger i life science

I det nyeste nummer af Pharma kan du læse om vores kollega Charlotte Lindorf Eriksen og hendes arbejde med pharmacovigilance som dyrlæge i Billev Pharma Pharma nr. 3 2023—Side 14 ( Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...