
Mette Skaarup Pedersen
Cand.Scient.Pharm., Senior Regulatory Affairs Manager
Mette Skaarup Pedersen is M.Sc. in Pharmaceutical sciences and has been with Billev Pharma since September 2008 as a Regulatory Affairs Manager. As of October 2023 Mette will hold the position as Senior Regulatory Affairs Manager.
- Has more than 10 years of experience within Regulatory Affairs and works mainly with DCP, MRP and national procedures.
- Wide experience with translation and proofreading of product information (SmPC, PL and labelling) and proofreading of mock-ups
Works both with human and veterinary medicinal products.
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.
Latest News
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