Are you lacking the capacity or qualification to perform an audit?

Aug 30, 2023

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 as globally. We can also audit your pharmacovigilance system according to the new veterinary EU regulation 2019/6, your contract takers e.g. transportation companies according to GDP and your GMP sites performing relabelling, repackaging and QP re-certification within the EU.

Would you like to have an external expert opinion at your self-inspection, or do you need a qualified auditor? Then our competent audit team consisting of Charlotte Lindorf Eriksen, Lisbeth Bonde Jensen, Laura Sparving, Trine Lorentzen and Ulrikke Lynge Jensen are the right choice.

You can read more about the 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.