Our regulatory team

Jan 15, 2020

As of January 2020, Karen Jensen will hold the position as Head of Regulatory Affairs and Charlotte Munk Ejlersen now holds the position as Senior Regulatory Affairs Manager.

Karen and Charlotte, together with the rest of our regulatory team, achieve high quality output and have specialized qualifications within all fields of regulatory affairs.

On 30-31 January you have the opportunity to meet Karen in Amsterdam at the Regulatory Affairs conference arranged by Medicines for Europe.

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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.