CP approval granted exceptionally fast

Jan 25, 2023

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 one of our key colleagues who facilitated the approval of a marketing authorisation through the centralised procedure in 2022. The approval was granted exceptionally fast; 1 year after the application was submitted to the EMA.

You can read more about Trine’s qualifications and our regulatory team here: The Billev Pharma Team

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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.