We experience increasing demand for our regulatory services

Jun 25, 2021

and our team working with preparation and review of analytical and pharmaceutical documentation is growing.

In May Lone Pallesen, B.Sc. Ing. in chemistry joined our regulatory team. Lone holds a Diploma in Regulatory Affairs from Medicademy and has more than 20 years’ experience within this field. She is specialised in quality/CMC requirements and in writing and review of module 3 documentation.

You can read more about Lone’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.