We now cover all areas within regulatory affairs

Aug 22, 2019

In February 2019 Susanne Thiilborg, Ph.D.Pharm., began a position as Regulatory Affairs Manager with Billev Pharma. Susanne has more than 20 years’ experience within analytical chemistry from the pharmaceutical company Lundbeck.

Susanne accounts for all possibilities and reviews the relevant issue from all aspects before drawing a conclusion.

With her extensive experience Susanne can help you with writing and reviewing the regulatory documentation for clinical trials (IMPD, IND), initial MAA/NDAs or maintenance activities such as variation applications. Also, she is able to assist you with compliance projects identifying and cleaning up GAPs in your quality documentation.

We are happy that Susanne has joined our company. With Susanne on our regulatory team we now cover all areas within regulatory affairs.

You can read more about Susanne’s qualifications on our website 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.