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
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.
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