Tina Nielsen
M.Sc. Pharm., Regulatory Manager
Tina Nielsen holds a M. Sc. Pharm. from Copenhagen University and has been with Billev Pharma since July 2025 as a Regulatory Affairs Manager.
Tina has more than 13 years’ experience in Regulatory Affairs from both affiliate and headquarter of Global Pharmaceutical Companies.
Tina’s experience covers:
- National, MR and DC procedures
- Centralised procedures
- Initial MAA and life-cycle maintenance
- Product information updates and artwork review
- eSubmissions
- Global regulatory strategies and scientific advice
In addition, she has 9 years experience with Pharmacovigilance post-marketing for human medicines (case handling, safety update report writing and signal detection).
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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