We offer full time and part time responsible person (RP) function for your wholesale distribution company and qualified person (QP) function for your manufacturing and import company including batch release of human and veterinary medicinal products prior to sale or supply.
Please consider our services if you do not have the expertise in-house or you are in need of qualified personnel for a shorter or longer period.
We also offer:
- assistance and guidance within quality assurance and quality control including RP and QP consultancy assistance e.g. if you are in the need of a deputy
- review of your company’s existing quality system to comply with the current GDP or GMP legislation
- update of your existing quality system i.e. quality manual and SOPs, and preparation of new to comply with the current GDP or GMP legislation
- preparation for inspection by the national agencies
- conduction of audit of your contract acceptor
- conduction of shelf-inspection together with the RP or QP
- assistance with maintenance of your company authorisation
Normally, the Danish Medicines Agency requires QP to spend at least 10 hours a week in the company in question. However, for small companies and/or small campaigns a reduced presence may be accepted.
For the RP the Danish Medicines Agency requires the person to be at the company on a regular basis and to an adequate extent taking into account the company’s activities.
The RP and QP must personally enter into a contract with your company.
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...