Anja van Arkens

Anja van Arkens
M.Sc.Pharm., Director & Owner

Anja van Arkens is M.Sc. Pharmacy and has been with Billev Pharma since September 2008 as a Regulatory Affairs Manager. 1 May 2011 Anja van Arkens became partner in Billev Pharma and in May 2015 she took over the position as Managing Director together with Ulrikke Lynge Jensen.

More than 16 years of experience from the Danish Medicines Agency as a Quality assessor including:

  • Pharmaceutical-chemical assessment of all types of marketing authorisation and variation applications including human and veterinary products.
  • Member of EMEA Quality Working Party (QWP).
  • Assessor at EDQM for Ph.Eur. certificates (CEP).
  • Laboratory control of medicines and Ph.Eur. draft monograph laboratory testing.
  • Member of EDQM Expert group 10A (elaboration of monographs for synthetic substances).
  • Former course leader at postgraduate courses for pharmacists in marketing authorisation for medicines at Pharmakon.

Speaker at various postgraduate courses for pharmacists e.g. stability.

Qualified Person for smaller companies. Experience with GMP audits and inspections as well as batch review and review of analytical testing.

Trained in and working with GDP.

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.

Latest News

Simple solutions in a complex PV environment

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...

Dyrlæger i life science

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...