Senior State-Authorised Translator & Regulatory Affairs Officer
Maria Brogaard has a Master degree in Translation and Interpretation and has been with Billev Pharma since June 2004. As of March 2023 Maria will also hold the position as Regulatory Affairs Officer which involves handling of regulatory maintenance activities e.g. variation applications. As of March 2023 Maria will hold the position as Senior State-Authorised Translator & Regulatory Affairs Officer.
- Is a state-authorised translator and interpreter.
- Has more than 15 years of experience as a medical translator and is involved in national procedures, MRPs, DCPs and CPs for both human and veterinary medicinal products.
- Works with all aspects of translation, proof-reading, submission and contact to relevant authorities.
- Provides certified translations.
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.
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.
At Billev Pharma we have a team of qualified lead auditors within GVP, VGVP, GMP and GDP. Last year our audit team conducted more than 10 remote pharmacovigilance audits and 10 onsite GDP audits of warehouses. We conduct remote and onsite audits within the EU as well...
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...
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 (ipaper.io). Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...