Could you use a helping hand in your regulatory department, or do you lack the specialised staff in-house to handle European procedures?

Mar 28, 2019

In June 2018 Karen Jensen, M.Sc. Pharm., joined our regulatory team. Karen and our regulatory team can assist you with both European and national initial MAAs or maintenance activities.

Karen is a generous co-worker and has more than 16 years of experience working as Special Adviser with the Danish Medicines Agency. She has a flair for quickly identifying the heart of the matter and for problem solving. Karen has excellent communication skills, also when it comes to extremely specialized topics, and it goes without saying that she strives to meet the deadline. Karen joining our team has indeed strengthened our knowledge within regulatory affairs. You can read more about Karen’s qualifications here: https://billevpharma.dk/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.