Extension of our RA team with an experienced Regulatory CMC specialist

Nov 20, 2020

Karina Rebild joined Billev Pharma as a Regulatory CMC Specialist in August. With her more than 30 years’ experience – including sterile production and regulatory lifecycle management – she brings valuable knowledge to our RA team, which currently counts 15 colleagues. Karina is mainly working for our new major client. The client has chosen to outsource some of their regulatory work to us based on the wide-range knowledge and experience in our Regulatory Affairs Specialist Team and our highly scientific work environment with professional back-and-forts.

You can read more about Karina’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.